Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
Sponsor
Repros Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00958334
Collaborator
(none)
65
11
3
25.3
5.9
0.2
Study Details
Study Description
Brief Summary
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003
Actual Study Start Date
:
Sep 7, 2006
Actual Primary Completion Date
:
Oct 15, 2008
Actual Study Completion Date
:
Oct 15, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Proellex 25 mg Two Proellex® 12.5 mg capsules once daily |
Drug: Proellex®
25 mg daily (two 12.5 mg capsules)
Other Names:
|
| Experimental: Proellex 12.5 mg One Proellex® 12.5 mg capsules once daily |
Drug: Proellex®
25 mg daily (two 12.5 mg capsules)
Other Names:
|
| Placebo Comparator: Placebo Capsule once a day |
Drug: Proellex®
25 mg daily (two 12.5 mg capsules)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. [Baseline to 17 months]
An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.
Secondary Outcome Measures
- Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) [Baseline, 14 months, 17 months]
Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.
Exclusion Criteria:
-
Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
-
Pregnant or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Women's Health Research | Phoenix | Arizona | United States | 85015 |
| 2 | Arizona Wellness Centre for Women | Phoenix | Arizona | United States | 85032 |
| 3 | Medical Centre for Clinical Research | San Diego | California | United States | 92108 |
| 4 | Women's Health Care, Inc. | San Diego | California | United States | 92123 |
| 5 | Downtown Women's Health Care | Denver | Colorado | United States | 80218 |
| 6 | Insignia Clinical Research (Tampa Bay Women's Center) | Tampa | Florida | United States | 33607 |
| 7 | Affiliated Clinical Research, Inc. | Las Vegas | Nevada | United States | 89128 |
| 8 | SC Clinical Research Center | Columbia | South Carolina | United States | 29201 |
| 9 | Advances in Health Inc. | Houston | Texas | United States | 77030 |
| 10 | Obstetrical & Gynecolgical Associates, PA (OGA) | Houston | Texas | United States | 77054 |
| 11 | Women's Clinical Research Centre | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Repros Therapeutics Inc.
Investigators
- Study Director: Anna Chan, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958334
Other Study ID Numbers:
- ZPU-003 Ext
First Posted:
Aug 13, 2009
Last Update Posted:
Jun 18, 2019
Last Verified:
May 1, 2019
Keywords provided by Repros Therapeutics Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | ZPU-003 EXT was an open-label extension study of ZPU-003 (NCT00882258) and all patients received active medication (25 mg of Proellex); results were summarized according to the following groups - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study. |
| Arm/Group Title | Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex |
|---|---|---|---|
| Arm/Group Description | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| Period Title: Overall Study | |||
| STARTED | 22 | 22 | 21 |
| COMPLETED | 8 | 5 | 8 |
| NOT COMPLETED | 14 | 17 | 13 |
Baseline Characteristics
| Arm/Group Title | Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | Total of all reporting groups |
| Overall Participants | 22 | 22 | 21 | 65 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
22
100%
|
22
100%
|
21
100%
|
65
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
41.5
(5.55)
|
42.6
(5.38)
|
40.6
(6.48)
|
41.6
(5.78)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
22
100%
|
22
100%
|
21
100%
|
65
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
22
100%
|
22
100%
|
21
100%
|
65
100%
|
Outcome Measures
| Title | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. |
|---|---|
| Description | An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data. |
| Time Frame | Baseline to 17 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population |
| Arm/Group Title | Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex |
|---|---|---|---|
| Arm/Group Description | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| Measure Participants | 22 | 22 | 21 |
| Baseline |
136.29
(88.12)
|
179.95
(119.83)
|
130.86
(147.10)
|
| Change from baseline to end of ODI 1 |
-41.00
(71.63)
|
-63.57
(100.83)
|
|
| Change from baseline to end of ODI 2 |
-38.60
(69.30)
|
-33.33
(213.63)
|
-9.90
(125.88)
|
| Change from baseline to end of ODI 3 |
-7.00
(69.63)
|
-222.50
(121.62)
|
-31.29
(175.46)
|
| Change from baseline to end of ODI 4 |
-48.00
(11.31)
|
||
| Change from baseline to 17 months |
1.43
(94.09)
|
-211.40
(148.06)
|
17.50
(192.88)
|
| Title | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) |
|---|---|
| Description | Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood. |
| Time Frame | Baseline, 14 months, 17 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population |
| Arm/Group Title | Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex |
|---|---|---|---|
| Arm/Group Description | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| Measure Participants | 22 | 22 | 21 |
| Change from baseline to month 14 |
-150.67
(66.89)
|
-248.67
(174.37)
|
-654.00
(NA)
|
| Change from baseline to month 17 |
-25.33
(48.01)
|
-230.00
(240.02)
|
Adverse Events
| Time Frame | 24 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ZPU-003 EXT was an open-label extension study of ZPU-003 (NCT00882258) and all patients received active medication (25 mg of Proellex); however, results were summarized according to the following groups - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study. | |||||
| Arm/Group Title | Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex | |||
| Arm/Group Description | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | |||
All Cause Mortality |
||||||
| Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/22 (9.1%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| Gastrointestinal disorders | ||||||
| Colitis | 1/22 (4.5%) | 1 | 0/22 (0%) | 0 | 0/21 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Autoimmune hepatitis | 1/22 (4.5%) | 1 | 0/22 (0%) | 0 | 0/21 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Ovarian cyst ruptured | 0/22 (0%) | 0 | 0/22 (0%) | 0 | 1/21 (4.8%) | 1 |
| Vascular disorders | ||||||
| Uterine Haemorrhage | 0/22 (0%) | 0 | 1/22 (4.5%) | 2 | 0/21 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Proellex 25 mg | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/22 (86.4%) | 18/22 (81.8%) | 19/21 (90.5%) | |||
| Blood and lymphatic system disorders | ||||||
| anemia | 1/22 (4.5%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| Gastrointestinal disorders | ||||||
| nausea | 2/22 (9.1%) | 3/22 (13.6%) | 3/21 (14.3%) | |||
| abdominal pain | 1/22 (4.5%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| diarrhea | 1/22 (4.5%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| vomiting | 0/22 (0%) | 3/22 (13.6%) | 0/21 (0%) | |||
| abdominal distension | 1/22 (4.5%) | 0/22 (0%) | 1/21 (4.8%) | |||
| colitis | 2/22 (9.1%) | 0/22 (0%) | 0/21 (0%) | |||
| constipation | 1/22 (4.5%) | 0/22 (0%) | 1/21 (4.8%) | |||
| General disorders | ||||||
| hot flush | 5/22 (22.7%) | 5/22 (22.7%) | 8/21 (38.1%) | |||
| fatigue | 1/22 (4.5%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| Infections and infestations | ||||||
| urinary tract infection | 0/22 (0%) | 0/22 (0%) | 5/21 (23.8%) | |||
| influenza | 3/22 (13.6%) | 1/22 (4.5%) | 3/21 (14.3%) | |||
| Injury, poisoning and procedural complications | ||||||
| joint sprain | 1/22 (4.5%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| Investigations | ||||||
| hepatic enzyme increased | 0/22 (0%) | 1/22 (4.5%) | 2/21 (9.5%) | |||
| blood cholesterol increased | 2/22 (9.1%) | 0/22 (0%) | 0/21 (0%) | |||
| prothrombin level increased | 1/22 (4.5%) | 1/22 (4.5%) | 0/21 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| arthralgia | 3/22 (13.6%) | 2/22 (9.1%) | 1/21 (4.8%) | |||
| back pain | 1/22 (4.5%) | 0/22 (0%) | 2/21 (9.5%) | |||
| pain in extremity | 2/22 (9.1%) | 0/22 (0%) | 1/21 (4.8%) | |||
| myalgia | 0/22 (0%) | 2/22 (9.1%) | 0/21 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| uterine polyp | 1/22 (4.5%) | 1/22 (4.5%) | 0/21 (0%) | |||
| Nervous system disorders | ||||||
| headache | 7/22 (31.8%) | 2/22 (9.1%) | 5/21 (23.8%) | |||
| dizziness | 2/22 (9.1%) | 2/22 (9.1%) | 0/21 (0%) | |||
| carpal tunnel syndrome | 2/22 (9.1%) | 1/22 (4.5%) | 0/21 (0%) | |||
| Psychiatric disorders | ||||||
| anxiety | 2/22 (9.1%) | 1/22 (4.5%) | 0/21 (0%) | |||
| depression | 1/22 (4.5%) | 0/22 (0%) | 1/21 (4.8%) | |||
| Reproductive system and breast disorders | ||||||
| endometrial thickening | 8/22 (36.4%) | 6/22 (27.3%) | 2/21 (9.5%) | |||
| amenorrhea | 5/22 (22.7%) | 4/22 (18.2%) | 6/21 (28.6%) | |||
| menorrhagia/uterine hemorrhage/metorrhagia | 4/22 (18.2%) | 3/22 (13.6%) | 2/21 (9.5%) | |||
| ovarian cyst | 3/22 (13.6%) | 3/22 (13.6%) | 1/21 (4.8%) | |||
| vulvovaginal mycotic infection | 2/22 (9.1%) | 0/22 (0%) | 2/21 (9.5%) | |||
| breast tenderness | 3/22 (13.6%) | 2/22 (9.1%) | 0/21 (0%) | |||
| dysmenorrhoea | 2/22 (9.1%) | 1/22 (4.5%) | 0/21 (0%) | |||
| breast cyst | 1/22 (4.5%) | 0/22 (0%) | 1/21 (4.8%) | |||
| cervical dysplasia | 1/22 (4.5%) | 1/22 (4.5%) | 0/21 (0%) | |||
| pelvic pain | 0/22 (0%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
| vaginitis bacterial | 1/22 (4.5%) | 0/22 (0%) | 1/21 (4.8%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| upper respiratory tract infection | 0/22 (0%) | 0/22 (0%) | 5/21 (23.8%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| acne | 1/22 (4.5%) | 1/22 (4.5%) | 0/21 (0%) | |||
| dermal cyst | 0/22 (0%) | 1/22 (4.5%) | 1/21 (4.8%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Allergan |
| Phone | 714-246-4500 |
| IR-CTRegistration@allergan.com |
Responsible Party:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958334
Other Study ID Numbers:
- ZPU-003 Ext
First Posted:
Aug 13, 2009
Last Update Posted:
Jun 18, 2019
Last Verified:
May 1, 2019