Study Stopped
Repros stopped study for safety and the FDA put the study on hold for safety.
Study to Evaluate Menses Induction in Women Administered Proellex
An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
August 25, 2014
CompletedAugust 25, 2014
August 1, 2014
6 months
April 14, 2009
June 26, 2014
August 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.
An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
Secondary Outcomes (1)
Duration of Vaginal Bleeding Following Treatment With Proellex.
At least 2 days
Study Arms (5)
Placebo
PLACEBO COMPARATORInitiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
3 mg Proellex
EXPERIMENTALFirst Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
6 mg Proellex
EXPERIMENTALSecond Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
12 mg Proellex
EXPERIMENTALThird Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
25 mg Proellex
EXPERIMENTALFourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical laboratory tests within normal ranges
- A normal menstrual period of 26-30 days
- Desiring not to become pregnant
- Agreeing to use a double barrier method of birth control for the duration of the trial
You may not qualify if:
- Post-menopausal status
- Aamenorrhea or dysfunctional uterine bleeding
- Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
- Subjects with a Body Mass Index (BMI) below 18 or over 39
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Advances in Health Inc.
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.
Results Point of Contact
- Title
- Jennifer Wike
- Organization
- Repros Therapeutics
Study Officials
- STUDY DIRECTOR
Andre van As, M.D., Ph.D
Repros Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 15, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 25, 2014
Results First Posted
August 25, 2014
Record last verified: 2014-08