Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Study Details
Study Description
Brief Summary
The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a randomized, open-label, active-controlled, multicenter study in healthy sexually active females to evaluate cycle control with norgestimate/ethinyl estradiol versus drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up to 35 days prior to dosing to obtain informed consent, have a physical examination including a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test performed, and to give their medical history. Patients will be instructed to report bleeding data using an interactive voice response system (IVRS) based diary on a daily basis. Patients will be instructed to continue taking 1 pill each day for 3 cycles, record this information daily in the IVRS and to contact the study site if they have any questions or adverse events they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after completing 3 cycles of study medication. Patients will be weighed, have vital signs performed, report any adverse events and or changes in concomitant medications, and complete the satisfaction questionnaire at the final visit. Safety will be assessed by physical examinations, adverse events, body weight and vital signs. Patients randomized to drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium levels (as outlined in the Package Insert) will also have their potassium level checked during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Days of Unscheduled Blood Loss - Cycle 1 [Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)]
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Number of Days of Unscheduled Blood Loss - Cycle 2 [Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)]
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Number of Days of Unscheduled Blood Loss - Cycle 3 [Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)]
Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Overall Number of Days of Unscheduled Blood Loss [Cycle 1 to Cycle 3 (Day 8 to Day 80)]
cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes [Cycle 1 to Cycle 3 (Day 8 to Day 80)]
Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.
- Number of Days of Scheduled Blood Loss - Cycle 1 [Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)]
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
- Number of Days of Scheduled Blood Loss - Cycle 2 [Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)]
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
- Number of Days of Scheduled Blood Loss - Cycle 3 [Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)]
cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
- Overall Number of Days of Scheduled Blood Loss [Cycle 1 to Cycle 3 (Day 8 to Day 84)]
summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.
- Number of Days of Total Blood Loss - Cycle 1 [Cycle 1 (Day 8 to Day 28)]
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
- Number of Days of Total Blood Loss - Cycle 2 [Cycle 2 (day 29 to Day 56)]
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
- Number of Days of Total Blood Loss - Cycle 3 [Cycle 3 (Day 57 to Day 84)]
cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
- Overall Number of Days of Total Blood Loss [Cycle 1 to 3 (Day 8 to Day 84)]
cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.
- Number of Participants With Unscheduled Bleeding Cycle 1 [Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)]
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Number of Participants With Unscheduled Bleeding Cycle 2 [Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)]
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Number of Participants With Unscheduled Bleeding Cycle 3 [Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)]
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
- Number of Participants With Breakthrough Bleeding/Spotting Cycle 1 [Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)]
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
- Number of Participants With Breakthrough Bleeding/Spotting Cycle 2 [Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)]
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
- Number of Participants With Breakthrough Bleeding/Spotting Cycle 3 [Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)]
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.
Secondary Outcome Measures
- Patient Satisfaction - Overall [Cycle 1 to Cycle 3]
patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy females who want oral contraception
-
No cervical or vaginal abnormalities on gynecological examination
-
Negative Chlamydia test
-
Pap smear without evidence of moderate or severe dysplasia or any malignancy within the preceding 12 months
-
Negative urine pregnancy test conducted during Visit 1
-
One normal menstrual period in 35 days prior to Visit 1
-
Regular menstrual cycles (every 26-35 days)
-
Last term pregnancy at least 42 days prior to Visit 1, and have had at least one normal menstrual period (typical in duration and amount of flow for the subject) since her last pregnancy
-
Post-menarcheal and pre-menopausal
-
At least one normal menstrual period (typical in duration and amount of flow for the subject) since having undergone uterines urgery or removal of an IUD, Norplant, DepoProvera or other hormonal injectables or implants.
Exclusion Criteria:
-
History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy
-
Previously discontinued ORTHO TRI-CYCLEN LO or YAZ due to breakthrough bleeding
-
Pregnant or lactating
-
Body mass index (BMI) of >40kg/m2
-
Clinical evidence of carcinoma or other malignancy (history of basal cell carcinoma of the skin is not exclusionary)
-
History of alcohol or drug abuse in the investigator's judgment based on history and physical examination (within 12 months prior to Visit 1)
-
Significant depression or psychiatric disease in the investigator's judgment based on history and physical examination which would result in an unreliable patient
-
Patient deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information
-
Have any medical condition or planned surgical procedure which, in the opinion of the investigator, may be exacerbated by treatment with study medication or a patient receiving any concurrent therapy that could be affected by treatment with study medication
-
Disallowed therapies: currently taking therapeutic anticoagulants (e.g,. Coumadin, Heparin) or have a bleeding disorder (e.g. von Willebrand's Disease), DepoProvera or other hormonal injectables in the six months before Visit 1, currently have Norplant or other hormonal implants in place, or have had removal of Norplant within 60 days prior to Visit 1, used a steroid-containing IUD within 3 months prior to Visit 1
-
Or current use of an IUD
-
Consistently elevated blood pressure defined as sitting systolic BP>140 mmHg or diastolic BP>90 mmHg
-
Have an untreated thyroid disorder in the investigator's judgment based on history and physical examination
-
unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
-
Patients who in the opinion of the investigator should not be enrolled in the study based on the product labeling for ORTHO TRI-CYCLEN LO and YAZ including potential drug-drug interactions
-
Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
- Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Ortho-McNeil Janssen Scientific Affairs, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CR015055
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Period Title: Overall Study | ||
| STARTED | 178 | 177 |
| COMPLETED | 154 | 156 |
| NOT COMPLETED | 24 | 21 |
Baseline Characteristics
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE | Total |
|---|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients | Total of all reporting groups |
| Overall Participants | 178 | 177 | 355 |
| Age, Customized (participants) [Number] | |||
| <18 years |
0
0%
|
0
0%
|
0
0%
|
| >= 18 and < 65 years |
178
100%
|
177
100%
|
355
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
27.2
(6.70)
|
27.2
(6.52)
|
27.2
(6.60)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
178
100%
|
177
100%
|
355
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Days of Unscheduled Blood Loss - Cycle 1 |
|---|---|
| Description | cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Mean (Standard Deviation) [Days] |
1.9
(3.14)
|
2.0
(3.53)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9698 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Patient Satisfaction - Overall |
|---|---|
| Description | patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied. |
| Time Frame | Cycle 1 to Cycle 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Number of responses |
159
89.3%
|
162
91.5%
|
| 1. Very Satisfied |
99
55.6%
|
115
65%
|
| 2. Somewhat satisfied |
35
19.7%
|
32
18.1%
|
| 3. Neither satisfied or dissatisfied |
12
6.7%
|
6
3.4%
|
| 4. Dissatisfied |
11
6.2%
|
8
4.5%
|
| 5. Very dissatisfied |
2
1.1%
|
1
0.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0715 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Unscheduled Blood Loss - Cycle 2 |
|---|---|
| Description | cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 160 | 165 |
| Mean (Standard Deviation) [Days] |
1.3
(2.49)
|
1.9
(2.86)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0050 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Unscheduled Blood Loss - Cycle 3 |
|---|---|
| Description | Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 157 | 159 |
| Mean (Standard Deviation) [Days] |
1.4
(2.33)
|
2.4
(2.86)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Overall Number of Days of Unscheduled Blood Loss |
|---|---|
| Description | cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 1 to Cycle 3 (Day 8 to Day 80) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Mean (Standard Deviation) [Days] |
4.6
(5.33)
|
6.1
(6.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0031 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes |
|---|---|
| Description | Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day. |
| Time Frame | Cycle 1 to Cycle 3 (Day 8 to Day 80) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| 0 Episode |
55
30.9%
|
29
16.4%
|
| 1 Episode |
46
25.8%
|
41
23.2%
|
| 2 Episodes |
23
12.9%
|
50
28.2%
|
| 3 Episodes |
21
11.8%
|
22
12.4%
|
| 4 Episodes |
13
7.3%
|
11
6.2%
|
| 5 Episodes |
7
3.9%
|
8
4.5%
|
| 6 Episodes |
0
0%
|
2
1.1%
|
| 8 Episodes |
0
0%
|
3
1.7%
|
| 9 Episodes |
0
0%
|
1
0.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0013 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Scheduled Blood Loss - Cycle 1 |
|---|---|
| Description | cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Time Frame | Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Mean (Standard Deviation) [Days] |
4.3
(2.09)
|
3.2
(2.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Scheduled Blood Loss - Cycle 2 |
|---|---|
| Description | cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Time Frame | Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 160 | 165 |
| Mean (Standard Deviation) [Days] |
4.0
(2.15)
|
2.8
(2.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Scheduled Blood Loss - Cycle 3 |
|---|---|
| Description | cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Time Frame | Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 157 | 159 |
| Mean (Standard Deviation) [Days] |
3.1
(2.09)
|
1.2
(1.30)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Overall Number of Days of Scheduled Blood Loss |
|---|---|
| Description | summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Time Frame | Cycle 1 to Cycle 3 (Day 8 to Day 84) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Mean (Standard Deviation) [Days] |
11.2
(5.40)
|
7.0
(4.80)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Total Blood Loss - Cycle 1 |
|---|---|
| Description | cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. |
| Time Frame | Cycle 1 (Day 8 to Day 28) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Mean (Standard Deviation) [Days] |
6.2
(3.88)
|
5.2
(4.45)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0033 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Total Blood Loss - Cycle 2 |
|---|---|
| Description | cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. |
| Time Frame | Cycle 2 (day 29 to Day 56) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 160 | 165 |
| Mean (Standard Deviation) [Days] |
5.3
(2.66)
|
4.6
(3.25)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0060 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Days of Total Blood Loss - Cycle 3 |
|---|---|
| Description | cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. |
| Time Frame | Cycle 3 (Day 57 to Day 84) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 157 | 159 |
| Mean (Standard Deviation) [Days] |
4.6
(2.64)
|
3.6
(3.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Overall Number of Days of Total Blood Loss |
|---|---|
| Description | cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. |
| Time Frame | Cycle 1 to 3 (Day 8 to Day 84) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Mean (Standard Deviation) [Days] |
15.8
(6.58)
|
13.2
(6.90)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Participants With Unscheduled Bleeding Cycle 1 |
|---|---|
| Description | Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Number [Participants] |
72
40.4%
|
74
41.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.912 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Number of Participants With Unscheduled Bleeding Cycle 2 |
|---|---|
| Description | Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 160 | 165 |
| Number [Participants] |
57
32%
|
87
49.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Number of Participants With Unscheduled Bleeding Cycle 3 |
|---|---|
| Description | Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 157 | 159 |
| Number [Participants] |
65
36.5%
|
94
53.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Number of Participants With Breakthrough Bleeding/Spotting Cycle 1 |
|---|---|
| Description | Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding. |
| Time Frame | Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 165 | 167 |
| Number [Participants] |
53
29.8%
|
56
31.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.816 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Number of Participants With Breakthrough Bleeding/Spotting Cycle 2 |
|---|---|
| Description | Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding. |
| Time Frame | Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 160 | 165 |
| Number [Participants] |
39
21.9%
|
62
35%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Number of Participants With Breakthrough Bleeding/Spotting Cycle 3 |
|---|---|
| Description | Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Time Frame | Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. |
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE |
|---|---|---|
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients |
| Measure Participants | 157 | 159 |
| Number [Participants] |
47
26.4%
|
74
41.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | NGM/25mcg EE, DRSP/20mcg EE |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Total participants at risk is based on safety population, which is defined as participants who took at least one dose of study drug. Based on this definition, the total participants at risk are 167 for each of the two treatment groups. | |||
| Arm/Group Title | NGM/25mcg EE | DRSP/20mcg EE | ||
| Arm/Group Description | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients | ||
All Cause Mortality |
||||
| NGM/25mcg EE | DRSP/20mcg EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| NGM/25mcg EE | DRSP/20mcg EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/167 (1.2%) | 1/167 (0.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral disc protrusion | 1/167 (0.6%) | 0/167 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Uterine leiomyoma | 1/167 (0.6%) | 0/167 (0%) | ||
| Reproductive system and breast disorders | ||||
| Ovarian cyst ruptured | 1/167 (0.6%) | 0/167 (0%) | ||
| Pelvic hemorrhage | 1/167 (0.6%) | 0/167 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolism | 0/167 (0%) | 1/167 (0.6%) | ||
Other (Not Including Serious) Adverse Events |
||||
| NGM/25mcg EE | DRSP/20mcg EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/167 (20.4%) | 34/167 (20.4%) | ||
| Cardiac disorders | ||||
| Palpitations | 1/167 (0.6%) | 0/167 (0%) | ||
| Endocrine disorders | ||||
| Hypothyroidism | 0/167 (0%) | 1/167 (0.6%) | ||
| Eye disorders | ||||
| Vision blurred | 0/167 (0%) | 1/167 (0.6%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 1/167 (0.6%) | 0/167 (0%) | ||
| Nausea | 4/167 (2.4%) | 1/167 (0.6%) | ||
| Vomiting | 1/167 (0.6%) | 1/167 (0.6%) | ||
| General disorders | ||||
| Chest pain | 1/167 (0.6%) | 0/167 (0%) | ||
| Fatigue | 0/167 (0%) | 1/167 (0.6%) | ||
| Irritability | 1/167 (0.6%) | 4/167 (2.4%) | ||
| Infections and infestations | ||||
| Bronchitis | 1/167 (0.6%) | 0/167 (0%) | ||
| Gastroenteritis viral | 1/167 (0.6%) | 1/167 (0.6%) | ||
| Genital herpes | 1/167 (0.6%) | 0/167 (0%) | ||
| Localised infection | 1/167 (0.6%) | 0/167 (0%) | ||
| Pharyngitis streptococcal | 3/167 (1.8%) | 0/167 (0%) | ||
| Periorbital cellulitis | 0/167 (0%) | 1/167 (0.6%) | ||
| Sinusitis | 3/167 (1.8%) | 0/167 (0%) | ||
| Upper respiratory tract infection | 0/167 (0%) | 1/167 (0.6%) | ||
| Urinary tract infection | 1/167 (0.6%) | 0/167 (0%) | ||
| Vulval abscess | 1/167 (0.6%) | 0/167 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Joint sprain | 0/167 (0%) | 1/167 (0.6%) | ||
| Limb injury | 0/167 (0%) | 1/167 (0.6%) | ||
| Sunburn | 1/167 (0.6%) | 0/167 (0%) | ||
| Investigations | ||||
| Weight increased | 1/167 (0.6%) | 2/167 (1.2%) | ||
| Metabolism and nutrition disorders | ||||
| Fluid retention | 0/167 (0%) | 1/167 (0.6%) | ||
| Polydipsia | 0/167 (0%) | 1/167 (0.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/167 (0.6%) | 2/167 (1.2%) | ||
| Intervertebral disc protrusion | 1/167 (0.6%) | 0/167 (0%) | ||
| Muscle spasms | 0/167 (0%) | 1/167 (0.6%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Uterine leiomyoma | 1/167 (0.6%) | 0/167 (0%) | ||
| Nervous system disorders | ||||
| Headache | 2/167 (1.2%) | 2/167 (1.2%) | ||
| Migraine | 0/167 (0%) | 1/167 (0.6%) | ||
| Sinus headache | 0/167 (0%) | 1/167 (0.6%) | ||
| Tension headache | 2/167 (1.2%) | 1/167 (0.6%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 1/167 (0.6%) | 0/167 (0%) | ||
| Psychiatric disorders | ||||
| Anxiety disorder | 0/167 (0%) | 1/167 (0.6%) | ||
| Libido decreased | 0/167 (0%) | 1/167 (0.6%) | ||
| Mood swings | 3/167 (1.8%) | 5/167 (3%) | ||
| Mood altered | 1/167 (0.6%) | 0/167 (0%) | ||
| Panic disorder | 0/167 (0%) | 1/167 (0.6%) | ||
| Reproductive system and breast disorders | ||||
| Breast tenderness | 2/167 (1.2%) | 0/167 (0%) | ||
| Breast enlargement | 1/167 (0.6%) | 0/167 (0%) | ||
| Dysmenorrhea | 0/167 (0%) | 2/167 (1.2%) | ||
| Ovarian cyst ruptured | 1/167 (0.6%) | 0/167 (0%) | ||
| Pelvic hemorrhage | 1/167 (0.6%) | 0/167 (0%) | ||
| Pelvic pain | 0/167 (0%) | 1/167 (0.6%) | ||
| Vaginal cyst | 0/167 (0%) | 1/167 (0.6%) | ||
| Vaginal hemorrhage | 1/167 (0.6%) | 0/167 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolism | 0/167 (0%) | 1/167 (0.6%) | ||
| Rhinitis allergic | 0/167 (0%) | 1/167 (0.6%) | ||
| Rhinorrhea | 1/167 (0.6%) | 0/167 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 0/167 (0%) | 3/167 (1.8%) | ||
| Dermatitis allergic | 1/167 (0.6%) | 0/167 (0%) | ||
| Dermatitis contact | 0/167 (0%) | 1/167 (0.6%) | ||
| Pruritus | 0/167 (0%) | 1/167 (0.6%) | ||
| Urticaria | 0/167 (0%) | 1/167 (0.6%) | ||
| Surgical and medical procedures | ||||
| Liposuction | 1/167 (0.6%) | 0/167 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Scientific Officer |
|---|---|
| Organization | North America Pharmaceutical (Ortho-McNeil Janssen Scientific Affairs, LLC) |
| Phone | 1-888-526-5060 ext 2915 |
- CR015055