Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Study Details
Study Description
Brief Summary
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 4 Elagolix 400 mg QD Participants received elagolix 400 mg once a day (QD) for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
|
Experimental: Cohort 4 Elagolix 100 mg BID Participants received elagolix 100 mg twice a day (BID) for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
|
Placebo Comparator: Cohort 4 Placebo Participants received placebo to elagolix BID for 3 months. |
Drug: Placebo
Matching placebo tablets
|
Experimental: Cohort 1 Elagolix 200 mg BID Participants received elagolix 200 mg twice a day for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
|
Placebo Comparator: Cohort 1 Placebo Participants received placebo to elagolix twice a day for 3 months. |
Drug: Placebo
Matching placebo tablets
|
Placebo Comparator: Cohort 3 Elagolix 200 mg BID + LD E2/NETA Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
Drug: Estradiol/Norethindrone acetate (E2/NETA)
A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.
Other Names:
|
Experimental: Cohort 5 Elagolix 600 mg QD Participants received elagolix 600 mg once a day for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
|
Experimental: Cohort 2 Elagolix 300 mg BID Participants received elagolix 300 mg twice a day for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
|
Experimental: Cohort 2 Placebo Participants received placebo to elagolix BID for 3 months. |
Drug: Placebo
Matching placebo tablets
|
Experimental: Cohort 6 Elagolix 300 mg BID + CEP Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Drug: Elagolix
Elagolix tablets
Other Names:
Drug: Estradiol
1.0 mg micronized estradiol tablets administered once a day
Other Names:
Drug: Progesterone
Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) [Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)]
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Secondary Outcome Measures
- Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) [Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)]
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
- Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment [Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)]
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
- Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment [The last 28 days of treatment (approximately days 61 to 90)]
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
- Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment [Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)]
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
- Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 [Baseline and Month 3]
The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories: No change from baseline in hemoglobin Decrease from baseline in hemoglobin ≥ -0.5 g/dL Decrease from baseline in hemoglobin ≥ -1.0 g/dL Increase from baseline in hemoglobin ≥ 0.5 g/dL Increase from baseline in hemoglobin ≥ 1.0 g/dL The above categories are not all mutually exclusive or exhaustive.
- Change in Hemoglobin Concentration From Baseline to Month 3 [Baseline and Month 3]
- Change From Baseline to Month 3 in Uterine Bleeding Score [Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)]
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
- Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding [Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)]
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. A day with any uterine bleeding is defined as a days with a bleeding score ≥ 1.
- Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding [Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)]
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. A day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3.
- Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3 [Month 3 (average bleeding score over days 61 to 90)]
Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3.
- Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment [The last 56 days of treatment (approximately days 33 to 90)]
Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment. Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.
- Percent Change From Baseline to Month 3 in Uterine Volume [Baseline and month 3]
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
- Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit [Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.]
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
- Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid [Baseline and month 3]
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
- Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit [Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.]
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
- Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL) [Baseline and month 3]
The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components. Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.
- Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores [Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)]
The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary.
- Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0 [Baseline and month 3]
The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery). SSIQ included the 2 following questions: How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now? How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?
- Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0 [Baseline and month 3]
The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery). The PSIQ included the 2 following questions: How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now? How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is a pre-menopausal female 20 to 49 years of age.
-
Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:
-
At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
-
Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
-
Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
-
Subject has a history of regular menstrual cycles between 24 to 35 days.
-
Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.
Exclusion Criteria:
-
Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
-
Subject has a history of osteoporosis or other metabolic bone disease.
-
Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.
-
Subject has a history of clinically significant condition(s) including but not limited to:
-
Endometriosis
-
Epilepsy or seizures
-
Type 1 diabetes
-
Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
- M12-663
Study Results
Participant Flow
Recruitment Details | Overall, 271 female participants were enrolled into the study across 45 sites in the United States. |
---|---|
Pre-assignment Detail | Six cohorts of participants were enrolled, with 3 double-blind cohorts comparing elagolix with placebo, 2 open-label cohorts assessing add-back therapies, and 1 open-label cohort assessing the elagolix 600 mg QD dosing regimen. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Period Title: Overall Study | ||||||||||
STARTED | 32 | 33 | 16 | 35 | 18 | 34 | 30 | 30 | 16 | 27 |
COMPLETED | 26 | 27 | 13 | 28 | 16 | 29 | 24 | 26 | 14 | 25 |
NOT COMPLETED | 6 | 6 | 3 | 7 | 2 | 5 | 6 | 4 | 2 | 2 |
Baseline Characteristics
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP | Total |
---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. | Total of all reporting groups |
Overall Participants | 32 | 33 | 16 | 35 | 18 | 34 | 30 | 30 | 16 | 27 | 271 |
Age (years) [Mean (Standard Deviation) ] | |||||||||||
Mean (Standard Deviation) [years] |
40.8
(5.50)
|
42.1
(5.09)
|
41.1
(5.88)
|
43.1
(4.29)
|
44.0
(4.24)
|
40.9
(6.02)
|
40.8
(5.78)
|
42.6
(5.55)
|
41.6
(7.10)
|
41.6
(5.26)
|
41.8
(5.4)
|
Age, Customized (Count of Participants) | |||||||||||
< 35 years |
7
21.9%
|
3
9.1%
|
2
12.5%
|
2
5.7%
|
0
0%
|
5
14.7%
|
4
13.3%
|
3
10%
|
3
18.8%
|
3
11.1%
|
32
11.8%
|
35 to < 40 years |
6
18.8%
|
5
15.2%
|
5
31.3%
|
5
14.3%
|
2
11.1%
|
8
23.5%
|
6
20%
|
5
16.7%
|
3
18.8%
|
6
22.2%
|
51
18.8%
|
40 to < 45 years |
8
25%
|
13
39.4%
|
2
12.5%
|
13
37.1%
|
7
38.9%
|
10
29.4%
|
11
36.7%
|
9
30%
|
3
18.8%
|
10
37%
|
86
31.7%
|
≥ 45 years |
11
34.4%
|
12
36.4%
|
7
43.8%
|
15
42.9%
|
9
50%
|
11
32.4%
|
9
30%
|
13
43.3%
|
7
43.8%
|
8
29.6%
|
102
37.6%
|
Sex: Female, Male (Count of Participants) | |||||||||||
Female |
32
100%
|
33
100%
|
16
100%
|
35
100%
|
18
100%
|
34
100%
|
30
100%
|
30
100%
|
16
100%
|
27
100%
|
271
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||
Hispanic or Latino |
1
3.1%
|
8
24.2%
|
1
6.3%
|
1
2.9%
|
1
5.6%
|
1
2.9%
|
6
20%
|
0
0%
|
2
12.5%
|
12
44.4%
|
33
12.2%
|
Not Hispanic or Latino |
31
96.9%
|
25
75.8%
|
15
93.8%
|
34
97.1%
|
17
94.4%
|
33
97.1%
|
24
80%
|
30
100%
|
14
87.5%
|
15
55.6%
|
238
87.8%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||||||||||
White |
5
15.6%
|
10
30.3%
|
3
18.8%
|
7
20%
|
3
16.7%
|
7
20.6%
|
5
16.7%
|
6
20%
|
6
37.5%
|
11
40.7%
|
63
23.2%
|
Black |
25
78.1%
|
23
69.7%
|
13
81.3%
|
28
80%
|
14
77.8%
|
26
76.5%
|
24
80%
|
23
76.7%
|
9
56.3%
|
15
55.6%
|
200
73.8%
|
Asian |
1
3.1%
|
0
0%
|
0
0%
|
0
0%
|
1
5.6%
|
1
2.9%
|
0
0%
|
0
0%
|
1
6.3%
|
0
0%
|
4
1.5%
|
Other |
1
3.1%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
1
3.3%
|
0
0%
|
0
0%
|
3
1.1%
|
Multirace |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
1
0.4%
|
Outcome Measures
Title | Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) |
---|---|
Description | The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero. |
Time Frame | Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 31 | 31 | 15 | 32 | 18 | 33 | 28 | 30 | 15 | 26 |
Baseline |
213.70
(108.08)
|
269.36
(163.17)
|
321.73
(327.57)
|
335.11
(322.68)
|
251.72
(160.29)
|
247.70
(177.72)
|
215.62
(122.84)
|
206.27
(125.08)
|
349.17
(424.12)
|
257.99
(207.33)
|
Change from Baseline |
-183.97
(132.19)
|
-184.69
(187.05)
|
-10.46
(85.04)
|
-272.97
(271.39)
|
-79.00
(161.33)
|
-192.33
(191.51)
|
-189.05
(151.15)
|
-202.57
(127.93)
|
-175.31
(342.14)
|
-216.15
(157.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -205.9 | |
Confidence Interval |
(2-Sided) 95% -295.77 to -116.01 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 45.10 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -189.9 | |
Confidence Interval |
(2-Sided) 95% -278.33 to -101.53 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 44.36 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -138.0 | |
Confidence Interval |
(2-Sided) 95% -220.18 to -55.76 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 40.86 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -130.6 | |
Confidence Interval |
(2-Sided) 95% -206.70 to -54.60 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 37.68 |
|
Estimation Comments |
Title | Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) |
---|---|
Description | The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero. |
Time Frame | Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the electronic diary. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 31 | 31 | 15 | 32 | 18 | 33 | 28 | 30 | 15 | 26 |
Mean (Standard Deviation) [percent change] |
-83.83
(35.23)
|
-71.85
(49.20)
|
-6.98
(40.78)
|
-81.03
(55.77)
|
-11.12
(103.11)
|
-79.60
(43.63)
|
-88.58
(39.58)
|
-97.31
(12.57)
|
-42.64
(39.68)
|
-85.39
(28.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -75.60 | |
Confidence Interval |
(2-Sided) 95% -102.93 to -48.28 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.71 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -64.27 | |
Confidence Interval |
(2-Sided) 95% -91.14 to -37.39 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.48 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -67.67 | |
Confidence Interval |
(2-Sided) 95% -113.39 to -21.96 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 22.73 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS mean Difference |
Estimated Value | -56.84 | |
Confidence Interval |
(2-Sided) 95% -73.24 to -40.45 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.12 |
|
Estimation Comments |
Title | Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment |
---|---|
Description | The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero. |
Time Frame | Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 31 | 31 | 15 | 33 | 18 | 33 | 28 | 30 | 15 | 26 |
Number [percentage of participants] |
84
262.5%
|
74
224.2%
|
13
81.3%
|
85
242.9%
|
17
94.4%
|
85
250%
|
93
310%
|
97
323.3%
|
33
206.3%
|
85
314.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment |
---|---|
Description | The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero. |
Time Frame | The last 28 days of treatment (approximately days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 31 | 31 | 15 | 33 | 18 | 33 | 28 | 30 | 15 | 26 |
Number [percentage of participants] |
84
262.5%
|
74
224.2%
|
13
81.3%
|
85
242.9%
|
22
122.2%
|
88
258.8%
|
93
310%
|
97
323.3%
|
47
293.8%
|
88
325.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Elagolix 100 mg BID |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment |
---|---|
Description | The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero. |
Time Frame | Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 31 | 31 | 15 | 33 | 18 | 33 | 28 | 30 | 15 | 26 |
Number [percentage of participants] |
84
262.5%
|
74
224.2%
|
13
81.3%
|
91
260%
|
28
155.6%
|
85
250%
|
93
310%
|
97
323.3%
|
40
250%
|
88
325.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 |
---|---|
Description | The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories: No change from baseline in hemoglobin Decrease from baseline in hemoglobin ≥ -0.5 g/dL Decrease from baseline in hemoglobin ≥ -1.0 g/dL Increase from baseline in hemoglobin ≥ 0.5 g/dL Increase from baseline in hemoglobin ≥ 1.0 g/dL The above categories are not all mutually exclusive or exhaustive. |
Time Frame | Baseline and Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 23 | 24 | 11 | 27 | 14 | 28 | 23 | 25 | 14 | 21 |
No Change |
0
0%
|
0
0%
|
9
56.3%
|
0
0%
|
0
0%
|
0
0%
|
4
13.3%
|
0
0%
|
0
0%
|
5
18.5%
|
Decreases from -0.5 to 0 g/dL |
9
28.1%
|
17
51.5%
|
0
0%
|
4
11.4%
|
21
116.7%
|
14
41.2%
|
4
13.3%
|
0
0%
|
21
131.3%
|
5
18.5%
|
Decreases from -1.0 to -0.5 g/dL |
4
12.5%
|
4
12.1%
|
27
168.8%
|
11
31.4%
|
14
77.8%
|
0
0%
|
4
13.3%
|
0
0%
|
7
43.8%
|
10
37%
|
Increase ≥ 0.5 g/dL |
78
243.8%
|
71
215.2%
|
18
112.5%
|
67
191.4%
|
29
161.1%
|
75
220.6%
|
83
276.7%
|
76
253.3%
|
29
181.3%
|
71
263%
|
Increase ≥ 1.0 g/dL |
61
190.6%
|
71
215.2%
|
9
56.3%
|
59
168.6%
|
29
161.1%
|
43
126.5%
|
57
190%
|
52
173.3%
|
29
181.3%
|
62
229.6%
|
Title | Change in Hemoglobin Concentration From Baseline to Month 3 |
---|---|
Description | |
Time Frame | Baseline and Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 23 | 24 | 11 | 27 | 14 | 28 | 23 | 25 | 14 | 21 |
Mean (Standard Deviation) [g/dL] |
1.18
(0.99)
|
1.30
(1.19)
|
-0.43
(1.28)
|
1.13
(1.29)
|
0.28
(1.33)
|
0.92
(0.81)
|
1.40
(1.18)
|
1.19
(0.85)
|
0.31
(1.20)
|
1.54
(1.81)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% 0.97 to 2.56 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.40 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% 1.00 to 2.56 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.024 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% 0.13 to 1.75 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.40 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% 0.28 to 1.51 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
Estimation Comments |
Title | Change From Baseline to Month 3 in Uterine Bleeding Score |
---|---|
Description | Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. |
Time Frame | Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 30 | 30 | 15 | 32 | 17 | 32 | 26 | 27 | 15 | 25 |
Mean (Standard Deviation) [units on a scale] |
-0.50
(0.56)
|
-0.37
(0.46)
|
-0.19
(0.33)
|
-0.52
(0.65)
|
-0.22
(0.32)
|
-0.24
(0.47)
|
-0.44
(0.71)
|
-0.53
(0.33)
|
-0.38
(0.77)
|
-0.25
(0.64)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.011 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.36 | |
Confidence Interval |
(2-Sided) 95% -0.63 to -0.08 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.030 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.31 | |
Confidence Interval |
(2-Sided) 95% -0.59 to -0.03 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.109 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.26 | |
Confidence Interval |
(2-Sided) 95% -0.59 to 0.06 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.50 | |
Confidence Interval |
(2-Sided) 95% -0.80 to -0.19 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
Estimation Comments |
Title | Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding |
---|---|
Description | Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. A day with any uterine bleeding is defined as a days with a bleeding score ≥ 1. |
Time Frame | Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 30 | 30 | 15 | 32 | 17 | 32 | 26 | 27 | 15 | 25 |
Mean (Standard Deviation) [percentage of days] |
-15.22
(14.77)
|
-11.00
(15.52)
|
-5.78
(10.58)
|
-15.82
(17.88)
|
-6.99
(12.82)
|
3.63
(24.74)
|
-15.38
(23.21)
|
-16.91
(11.13)
|
-13.95
(23.83)
|
1.73
(26.09)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Elagolix 100 mg BID |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.020 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -10.29 | |
Confidence Interval |
(2-Sided) 95% -18.90 to -1.67 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.32 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.087 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -7.62 | |
Confidence Interval |
(2-Sided) 95% -16.36 to 1.13 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.39 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.045 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -8.81 | |
Confidence Interval |
(2-Sided) 95% -17.43 to -0.19 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.28 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -13.69 | |
Confidence Interval |
(2-Sided) 95% -22.06 to -5.32 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.14 |
|
Estimation Comments |
Title | Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding |
---|---|
Description | Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. A day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3. |
Time Frame | Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 30 | 30 | 15 | 32 | 17 | 32 | 26 | 27 | 15 | 25 |
Mean (Standard Deviation) [percentage of days] |
-7.22
(9.27)
|
-5.00
(7.87)
|
-4.00
(5.37)
|
-7.03
(10.89)
|
-3.08
(5.88)
|
-7.92
(6.43)
|
-6.15
(8.47)
|
-8.02
(5.41)
|
-3.31
(10.40)
|
-6.80
(10.69)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.008 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -5.51 | |
Confidence Interval |
(2-Sided) 95% -9.56 to -1.47 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.03 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.020 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -4.95 | |
Confidence Interval |
(2-Sided) 95% -9.11 to -0.80 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.08 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.194 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -3.63 | |
Confidence Interval |
(2-Sided) 95% -9.18 to 1.91 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.75 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | ||
Method | ANCOVA | |
Comments | ANCOVA model with treatment as a factor and baseline as a covariate. | |
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -7.20 | |
Confidence Interval |
(2-Sided) 95% -11.33 to -3.07 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.04 |
|
Estimation Comments |
Title | Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3 |
---|---|
Description | Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3. |
Time Frame | Month 3 (average bleeding score over days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 30 | 30 | 15 | 32 | 17 | 32 | 26 | 27 | 15 | 26 |
Any bleeding |
37
115.6%
|
57
172.7%
|
93
581.3%
|
47
134.3%
|
94
522.2%
|
78
229.4%
|
27
90%
|
26
86.7%
|
80
500%
|
69
255.6%
|
Moderate to Very Heavy Bleeding |
27
84.4%
|
40
121.2%
|
87
543.8%
|
28
80%
|
82
455.6%
|
31
91.2%
|
15
50%
|
7
23.3%
|
73
456.3%
|
35
129.6%
|
Title | Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment |
---|---|
Description | Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment. Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment. |
Time Frame | The last 56 days of treatment (approximately days 33 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants including participants with less than 56 days of treatment who bled but excluded those who did not bleed. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 30 | 29 | 15 | 32 | 18 | 32 | 26 | 29 | 16 | 26 |
Suppression of bleeding |
66
206.3%
|
45
136.4%
|
0
0%
|
66
188.6%
|
0
0%
|
31
91.2%
|
77
256.7%
|
79
263.3%
|
0
0%
|
32
118.5%
|
Amenorrhea |
60
187.5%
|
31
93.9%
|
0
0%
|
44
125.7%
|
0
0%
|
19
55.9%
|
73
243.3%
|
66
220%
|
0
0%
|
19
70.4%
|
Title | Percent Change From Baseline to Month 3 in Uterine Volume |
---|---|
Description | Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. |
Time Frame | Baseline and month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 22 | 20 | 9 | 22 | 12 | 22 | 20 | 20 | 12 | 11 |
Mean (Standard Deviation) [percent change] |
-21.01
(26.79)
|
-21.37
(24.84)
|
18.72
(15.59)
|
-21.68
(29.80)
|
-8.62
(20.58)
|
-17.43
(19.51)
|
-27.99
(23.34)
|
-33.25
(16.55)
|
-1.92
(17.52)
|
-10.06
(30.93)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Elagolix 100 mg BID |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.052 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Title | Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit |
---|---|
Description | Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. |
Time Frame | Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued. |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 30 | 30 | 15 | 31 | 18 | 33 | 27 | 29 | 15 | 24 |
Number [percentage of participants] |
53
165.6%
|
43
130.3%
|
7
43.8%
|
48
137.1%
|
11
61.1%
|
42
123.5%
|
56
186.7%
|
69
230%
|
7
43.8%
|
25
92.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Elagolix 100 mg BID |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.016 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.012 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid |
---|---|
Description | The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. |
Time Frame | Baseline and month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available fibroid volume data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 19 | 18 | 9 | 22 | 12 | 22 | 18 | 20 | 12 | 10 |
Mean (Standard Deviation) [percent change] |
14.23
(187.83)
|
-22.19
(51.14)
|
-7.26
(36.35)
|
-38.52
(41.72)
|
-2.05
(71.83)
|
-25.77
(46.64)
|
-16.60
(39.61)
|
-35.79
(24.49)
|
6.70
(45.42)
|
-4.94
(100.68)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Elagolix 100 mg BID |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.161 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.173 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.072 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | One-way Kruskal-Wallis test with treatment as a factor. |
Title | Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit |
---|---|
Description | The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. |
Time Frame | Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued. |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 28 | 29 | 15 | 31 | 17 | 33 | 25 | 29 | 15 | 21 |
Number [percentage of participants] |
57
178.1%
|
52
157.6%
|
33
206.3%
|
68
194.3%
|
35
194.4%
|
58
170.6%
|
60
200%
|
55
183.3%
|
27
168.8%
|
48
177.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 400 mg QD, Cohort 4 Elagolix 100 mg BID |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.203 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Cohort 4 Elagolix 100 mg BID, Cohort 4 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.342 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Cohort 1 Elagolix 200 mg BID, Cohort 1 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.038 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Cohort 2 Elagolix 300 mg BID, Cohort 2 Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.111 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL) |
---|---|
Description | The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components. Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life. |
Time Frame | Baseline and month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available UFS-QoL data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 23 | 21 | 9 | 26 | 13 | 22 | 20 | 25 | 13 | 14 |
Symptom severity |
-39.0
(24.70)
|
-33.2
(28.17)
|
-19.6
(32.80)
|
-31.6
(28.87)
|
-21.4
(20.63)
|
-20.3
(25.35)
|
-36.4
(24.74)
|
-44.1
(22.12)
|
-12.0
(22.49)
|
-39.1
(24.09)
|
HRQL total |
35.3
(21.87)
|
29.1
(30.96)
|
16.3
(30.43)
|
36.0
(27.91)
|
18.3
(36.66)
|
28.6
(24.12)
|
29.9
(30.72)
|
33.5
(29.42)
|
11.0
(20.90)
|
33.1
(30.34)
|
Title | Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores |
---|---|
Description | The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary. |
Time Frame | Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90) |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 18 | 18 | 9 | 18 | 11 | 22 | 16 | 20 | 9 | 11 |
Pelvic pain |
-1.0
(2.27)
|
-0.2
(2.39)
|
-0.3
(1.45)
|
-0.6
(1.75)
|
-1.4
(1.62)
|
-1.1
(1.35)
|
-0.9
(2.15)
|
-1.0
(1.75)
|
-1.2
(1.73)
|
-2.4
(3.00)
|
Fatigue |
-0.5
(1.26)
|
-0.0
(2.23)
|
-0.6
(1.45)
|
-0.6
(1.29)
|
-0.5
(1.69)
|
-1.2
(1.92)
|
-1.0
(2.57)
|
-1.5
(1.16)
|
-0.5
(2.88)
|
-2.1
(3.11)
|
Menstrual cramping |
-1.2
(1.31)
|
-0.7
(2.51)
|
-0.5
(1.55)
|
-0.9
(1.16)
|
-1.2
(0.80)
|
-0.9
(1.25)
|
-1.1
(1.35)
|
-1.2
(1.09)
|
-1.0
(2.33)
|
-1.3
(2.15)
|
Impact of uterine fibroids |
-1.1
(1.18)
|
-0.4
(1.86)
|
-0.8
(1.40)
|
-1.0
(1.37)
|
-1.0
(1.81)
|
-0.9
(1.62)
|
-1.7
(2.41)
|
-1.3
(1.11)
|
-1.0
(2.18)
|
-3.1
(2.78)
|
Title | Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0 |
---|---|
Description | The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery). SSIQ included the 2 following questions: How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now? How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now? |
Time Frame | Baseline and month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 23 | 21 | 9 | 9 | 6 | 22 | 20 | 25 | 13 | 14 |
Likelihood of having myomectomy |
-1.2
(3.68)
|
-3.1
(4.52)
|
1.0
(2.12)
|
-1.8
(4.70)
|
2.3
(5.35)
|
-1.4
(4.34)
|
-1.7
(4.18)
|
-0.6
(5.10)
|
0.4
(4.16)
|
0.1
(2.63)
|
Likelihood of having hysterectomy |
0.0
(4.04)
|
-1.9
(4.19)
|
2.0
(3.64)
|
-0.8
(4.91)
|
-0.3
(0.52)
|
-0.7
(3.10)
|
-0.8
(4.42)
|
0.2
(3.65)
|
0.0
(1.96)
|
-1.5
(3.92)
|
Title | Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0 |
---|---|
Description | The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery). The PSIQ included the 2 following questions: How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now? How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now? |
Time Frame | Baseline and month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3. |
Arm/Group Title | Cohort 4 Elagolix 400 mg QD | Cohort 4 Elagolix 100 mg BID | Cohort 4 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 1 Placebo | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 5 Elagolix 600 mg QD | Cohort 2 Elagolix 300 mg BID | Cohort 2 Placebo | Cohort 6 Elagolix 300 mg BID + CEP |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. |
Measure Participants | 23 | 21 | 9 | 9 | 7 | 22 | 20 | 24 | 13 | 14 |
Likelihood to recommend myomectomy |
-0.9
(2.86)
|
-1.3
(3.31)
|
-2.7
(3.53)
|
-0.8
(1.76)
|
0.7
(1.11)
|
-0.6
(2.97)
|
-1.3
(3.62)
|
-1.2
(3.59)
|
0.0
(3.25)
|
0.0
(3.94)
|
Likelihood to recommend hysterectomy |
-0.8
(3.34)
|
-1.8
(4.37)
|
-0.2
(3.15)
|
-2.2
(2.82)
|
0.4
(1.62)
|
-1.4
(3.08)
|
-2.3
(3.99)
|
-1.5
(3.96)
|
-0.6
(2.81)
|
-2.8
(2.98)
|
Adverse Events
Time Frame | From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months. | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||||||||||||
Arm/Group Title | Cohort 1 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 2 Placebo | Cohort 2 Elagolix 300 mg BID | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 4 Placebo | Cohort 4 Elagolix 100 mg BID | Cohort 4 Golix 400 mg QD | Cohort 5 Elagolix 600 mg QD | Cohort 6 Elagolix 300 mg BID + CEP | ||||||||||
Arm/Group Description | Participants received placebo to elagolix twice a day for 3 months. | Participants received elagolix 200 mg twice a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 300 mg twice a day for 3 months | Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. | Participants received placebo to elagolix BID for 3 months. | Participants received elagolix 100 mg twice a day (BID) for 3 months. | Participants received elagolix 400 mg once a day (QD) for 3 months. | Participants received elagolix 600 mg once a day for 3 months. | Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months. | ||||||||||
All Cause Mortality |
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Cohort 1 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 2 Placebo | Cohort 2 Elagolix 300 mg BID | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 4 Placebo | Cohort 4 Elagolix 100 mg BID | Cohort 4 Golix 400 mg QD | Cohort 5 Elagolix 600 mg QD | Cohort 6 Elagolix 300 mg BID + CEP | |||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 0/32 (0%) | 0/30 (0%) | 0/27 (0%) | ||||||||||
Serious Adverse Events |
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Cohort 1 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 2 Placebo | Cohort 2 Elagolix 300 mg BID | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 4 Placebo | Cohort 4 Elagolix 100 mg BID | Cohort 4 Golix 400 mg QD | Cohort 5 Elagolix 600 mg QD | Cohort 6 Elagolix 300 mg BID + CEP | |||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/18 (5.6%) | 0/35 (0%) | 0/16 (0%) | 1/30 (3.3%) | 0/34 (0%) | 2/16 (12.5%) | 2/33 (6.1%) | 0/32 (0%) | 2/30 (6.7%) | 0/27 (0%) | ||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||
ANAEMIA | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 2/16 (12.5%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 |
Gastrointestinal disorders | ||||||||||||||||||||
PANCREATITIS | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 0/32 (0%) | 1/30 (3.3%) | 1 | 0/27 (0%) | 1 | ||||||||
General disorders | ||||||||||||||||||||
NECROSIS | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 1/33 (3%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||||||
Hepatobiliary disorders | ||||||||||||||||||||
CHOLECYSTITIS | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 1/33 (3%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||||||
Metabolism and nutrition disorders | ||||||||||||||||||||
HYPOVOLAEMIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||
UTERINE LEIOMYOMA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 1/30 (3.3%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 1/33 (3%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||
Reproductive system and breast disorders | ||||||||||||||||||||
UTERINE HAEMORRHAGE | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 1/33 (3%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||||||
Surgical and medical procedures | ||||||||||||||||||||
ABORTION INDUCED | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 0/32 (0%) | 1/30 (3.3%) | 1 | 0/27 (0%) | 1 | ||||||||
Other (Not Including Serious) Adverse Events |
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Cohort 1 Placebo | Cohort 1 Elagolix 200 mg BID | Cohort 2 Placebo | Cohort 2 Elagolix 300 mg BID | Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Cohort 4 Placebo | Cohort 4 Elagolix 100 mg BID | Cohort 4 Golix 400 mg QD | Cohort 5 Elagolix 600 mg QD | Cohort 6 Elagolix 300 mg BID + CEP | |||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 8/18 (44.4%) | 26/35 (74.3%) | 10/16 (62.5%) | 20/30 (66.7%) | 20/34 (58.8%) | 9/16 (56.3%) | 20/33 (60.6%) | 24/32 (75%) | 22/30 (73.3%) | 11/27 (40.7%) | ||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||
ANAEMIA | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 1/30 (3.3%) | 1 | 0/34 (0%) | 1 | 1/16 (6.3%) | 1 | 2/33 (6.1%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||
LEUKOCYTOSIS | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
Gastrointestinal disorders | ||||||||||||||||||||
ABDOMINAL PAIN | 1/18 (5.6%) | 1 | 2/35 (5.7%) | 2 | 0/16 (0%) | 2 | 3/30 (10%) | 5 | 0/34 (0%) | 5 | 0/16 (0%) | 5 | 0/33 (0%) | 5 | 0/32 (0%) | 5 | 2/30 (6.7%) | 2 | 4/27 (14.8%) | 5 |
NAUSEA | 0/18 (0%) | 3/35 (8.6%) | 4 | 2/16 (12.5%) | 2 | 2/30 (6.7%) | 2 | 0/34 (0%) | 2 | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 5/32 (15.6%) | 5 | 9/30 (30%) | 9 | 4/27 (14.8%) | 4 | |
ABDOMINAL DISCOMFORT | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 1/30 (3.3%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
ABDOMINAL DISTENSION | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 2/30 (6.7%) | 2 | 0/34 (0%) | 2 | 1/16 (6.3%) | 1 | 1/33 (3%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||
ABDOMINAL PAIN LOWER | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 2/30 (6.7%) | 2 | 0/34 (0%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | |||
CONSTIPATION | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 2/16 (12.5%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||
DIARRHOEA | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 1/30 (3.3%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 3/30 (10%) | 3 | 3/27 (11.1%) | 3 | ||
GASTROOESOPHAGEAL REFLUX DISEASE | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 2/16 (12.5%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||
VOMITING | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 1/30 (3.3%) | 2 | 0/34 (0%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 2/30 (6.7%) | 2 | 0/27 (0%) | 2 | ||
DRY MOUTH | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 2/32 (6.3%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | |||||||
PEPTIC ULCER | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
General disorders | ||||||||||||||||||||
FATIGUE | 1/18 (5.6%) | 1 | 2/35 (5.7%) | 2 | 0/16 (0%) | 2 | 0/30 (0%) | 2 | 4/34 (11.8%) | 4 | 0/16 (0%) | 4 | 1/33 (3%) | 1 | 4/32 (12.5%) | 4 | 2/30 (6.7%) | 2 | 0/27 (0%) | 2 |
OEDEMA PERIPHERAL | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 2/32 (6.3%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 |
CHILLS | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
INFLUENZA LIKE ILLNESS | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
IRRITABILITY | 0/18 (0%) | 0/35 (0%) | 2/16 (12.5%) | 2 | 0/30 (0%) | 2 | 0/34 (0%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||
MALAISE | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
VESSEL PUNCTURE SITE PAIN | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
Immune system disorders | ||||||||||||||||||||
HYPERSENSITIVITY | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 0/32 (0%) | 0/30 (0%) | 2/27 (7.4%) | 2 | |||||||||
Infections and infestations | ||||||||||||||||||||
BRONCHITIS | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 2/34 (5.9%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 |
VAGINITIS BACTERIAL | 1/18 (5.6%) | 1 | 1/35 (2.9%) | 1 | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
FUNGAL INFECTION | 0/18 (0%) | 0/35 (0%) | 2/16 (12.5%) | 2 | 0/30 (0%) | 2 | 0/34 (0%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||
VULVOVAGINITIS | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
FURUNCLE | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
INFECTED BITES | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
NASOPHARYNGITIS | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 2/32 (6.3%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | |||||||
UPPER RESPIRATORY TRACT INFECTION | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 2/32 (6.3%) | 2 | 2/30 (6.7%) | 2 | 0/27 (0%) | 2 | |||||||
URINARY TRACT INFECTION | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 1/33 (3%) | 1 | 3/32 (9.4%) | 3 | 0/30 (0%) | 3 | 0/27 (0%) | 3 | ||||||
Injury, poisoning and procedural complications | ||||||||||||||||||||
LACERATION | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 0/32 (0%) | 2/30 (6.7%) | 2 | 0/27 (0%) | 2 | ||||||||
Investigations | ||||||||||||||||||||
BLOOD PRESSURE INCREASED | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 2/27 (7.4%) | 2 |
WEIGHT INCREASED | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
BLOOD GLUCOSE INCREASED | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
ALANINE AMINOTRANSFERASE INCREASED | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 1/32 (3.1%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
ASPARTATE AMINOTRANSFERASE INCREASED | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
Metabolism and nutrition disorders | ||||||||||||||||||||
DECREASED APPETITE | 0/18 (0%) | 2/35 (5.7%) | 2 | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |
DIABETES MELLITUS | 1/18 (5.6%) | 1 | 1/35 (2.9%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
BACK PAIN | 1/18 (5.6%) | 1 | 3/35 (8.6%) | 4 | 0/16 (0%) | 4 | 2/30 (6.7%) | 3 | 0/34 (0%) | 3 | 1/16 (6.3%) | 1 | 1/33 (3%) | 1 | 3/32 (9.4%) | 3 | 5/30 (16.7%) | 5 | 0/27 (0%) | 5 |
MUSCLE SPASMS | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 3/34 (8.8%) | 3 | 0/16 (0%) | 3 | 0/33 (0%) | 3 | 0/32 (0%) | 3 | 2/30 (6.7%) | 2 | 0/27 (0%) | 2 |
PAIN IN EXTREMITY | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 2/34 (5.9%) | 3 | 0/16 (0%) | 3 | 0/33 (0%) | 3 | 0/32 (0%) | 3 | 0/30 (0%) | 3 | 0/27 (0%) | 3 | ||||
ARTHRALGIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 3/33 (9.1%) | 3 | 1/32 (3.1%) | 1 | 2/30 (6.7%) | 3 | 0/27 (0%) | 3 | ||||||
OSTEOPENIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 0/33 (0%) | 2/32 (6.3%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | |||||||
Nervous system disorders | ||||||||||||||||||||
DIZZINESS | 0/18 (0%) | 2/35 (5.7%) | 2 | 2/16 (12.5%) | 2 | 3/30 (10%) | 3 | 3/34 (8.8%) | 3 | 0/16 (0%) | 3 | 1/33 (3%) | 1 | 3/32 (9.4%) | 3 | 6/30 (20%) | 6 | 0/27 (0%) | 6 | |
HEADACHE | 0/18 (0%) | 3/35 (8.6%) | 3 | 3/16 (18.8%) | 3 | 6/30 (20%) | 6 | 5/34 (14.7%) | 5 | 0/16 (0%) | 5 | 3/33 (9.1%) | 3 | 4/32 (12.5%) | 4 | 9/30 (30%) | 11 | 2/27 (7.4%) | 2 | |
MIGRAINE | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
BALANCE DISORDER | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
LETHARGY | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
Psychiatric disorders | ||||||||||||||||||||
DEPRESSION | 2/18 (11.1%) | 2 | 1/35 (2.9%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
MOOD SWINGS | 1/18 (5.6%) | 1 | 2/35 (5.7%) | 3 | 0/16 (0%) | 3 | 0/30 (0%) | 3 | 0/34 (0%) | 3 | 0/16 (0%) | 3 | 0/33 (0%) | 3 | 0/32 (0%) | 3 | 0/30 (0%) | 3 | 0/27 (0%) | 3 |
LIBIDO DECREASED | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 2/34 (5.9%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||||
ANXIETY | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 2/33 (6.1%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||||||
INSOMNIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 2/33 (6.1%) | 2 | 1/32 (3.1%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
Renal and urinary disorders | ||||||||||||||||||||
NEPHROLITHIASIS | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
POLLAKIURIA | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
URINARY INCONTINENCE | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
Reproductive system and breast disorders | ||||||||||||||||||||
DYSMENORRHOEA | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 1/32 (3.1%) | 1 | 0/30 (0%) | 1 | 2/27 (7.4%) | 2 |
MENORRHAGIA | 1/18 (5.6%) | 1 | 2/35 (5.7%) | 3 | 0/16 (0%) | 3 | 0/30 (0%) | 3 | 0/34 (0%) | 3 | 0/16 (0%) | 3 | 0/33 (0%) | 3 | 0/32 (0%) | 3 | 0/30 (0%) | 3 | 0/27 (0%) | 3 |
PELVIC PAIN | 0/18 (0%) | 2/35 (5.7%) | 2 | 0/16 (0%) | 2 | 0/30 (0%) | 2 | 0/34 (0%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | |
VULVOVAGINAL DRYNESS | 0/18 (0%) | 2/35 (5.7%) | 2 | 0/16 (0%) | 2 | 0/30 (0%) | 2 | 0/34 (0%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | |
AMENORRHOEA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 2/34 (5.9%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||||
BREAST CYST | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 2/34 (5.9%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||||
METRORRHAGIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 2/34 (5.9%) | 2 | 0/16 (0%) | 2 | 0/33 (0%) | 2 | 0/32 (0%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 | ||||
DYSPAREUNIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
OVARIAN CYST | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 0/16 (0%) | 2/33 (6.1%) | 2 | 1/32 (3.1%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
ASTHMA | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
DYSPNOEA | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
Skin and subcutaneous tissue disorders | ||||||||||||||||||||
ACNE | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 1/33 (3%) | 2 | 2/32 (6.3%) | 2 | 0/30 (0%) | 2 | 0/27 (0%) | 2 |
NIGHT SWEATS | 0/18 (0%) | 3/35 (8.6%) | 3 | 1/16 (6.3%) | 1 | 1/30 (3.3%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 1/33 (3%) | 1 | 2/32 (6.3%) | 3 | 0/30 (0%) | 3 | 0/27 (0%) | 3 | |
RASH GENERALISED | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
RASH MACULAR | 1/18 (5.6%) | 1 | 0/35 (0%) | 1 | 0/16 (0%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 |
DRY SKIN | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
HYPERHIDROSIS | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
CHLOASMA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
URTICARIA | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | |||||
Vascular disorders | ||||||||||||||||||||
HOT FLUSH | 1/18 (5.6%) | 1 | 19/35 (54.3%) | 20 | 3/16 (18.8%) | 3 | 15/30 (50%) | 15 | 9/34 (26.5%) | 9 | 2/16 (12.5%) | 2 | 15/33 (45.5%) | 16 | 20/32 (62.5%) | 21 | 15/30 (50%) | 15 | 5/27 (18.5%) | 5 |
SPIDER VEIN | 0/18 (0%) | 0/35 (0%) | 1/16 (6.3%) | 1 | 0/30 (0%) | 1 | 0/34 (0%) | 1 | 0/16 (0%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 0/30 (0%) | 1 | 0/27 (0%) | 1 | ||
HYPERTENSION | 0/18 (0%) | 0/35 (0%) | 0/16 (0%) | 0/30 (0%) | 0/34 (0%) | 1/16 (6.3%) | 1 | 0/33 (0%) | 1 | 0/32 (0%) | 1 | 3/30 (10%) | 3 | 0/27 (0%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title | Global Medical Services |
---|---|
Organization | AbbVie (prior sponsor, Abbott) |
Phone | 800-633-9110 |
- M12-663