Determination of the Lowest, Safe and Effective Dose of Proellex
A Single-Blind, Placebo Run-in, Phase I/II Study Comparing Five Oral Doses of Proellex®
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedJuly 28, 2014
June 1, 2014
1.6 years
August 20, 2010
June 23, 2014
June 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Induction Amenorrhea
Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
10 weeks
Study Arms (5)
ARM 1
EXPERIMENTAL1 mg Proellex
ARM 2
EXPERIMENTAL3 mg Proellex
ARM 3
EXPERIMENTAL6 mg Proellex
ARM 4
EXPERIMENTAL9 mg Proellex
ARM 5
EXPERIMENTAL12 mg proellex
Interventions
1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Eligibility Criteria
You may qualify if:
- Ability to understand and provide a written informed consent.
- Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:
- Excessive menstrual bleeding;
- Menstrual pain;
- Confirmed uterine fibroids; and
- Confirmed endometriosis
- Normal menstrual cycle of 26-32 days
- Agree not to attempt to become pregnant
- Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
- Ability to swallow gelatin capsules Ability to complete a daily subject diary
- Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
- Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
- A Body Mass Index (BMI) between 18 and 39 inclusive
- Is available for all treatment and follow-up visits
You may not qualify if:
- Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
- Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
- Women with abnormal liver enzymes or liver disease.
- Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
- Received an investigational drug in the 30 days prior to the screening for this study
- Women with a history of PCOS
- Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
- Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
- Women currently using narcotics
- Women currently taking cimetidine or spironolactone
- Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON Devlopment Solutions
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer L. Wike
- Organization
- Repros Therapeutics Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Laura M Sterling, MD
ICON Development Solutions
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2010
First Posted
August 23, 2010
Study Start
August 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 28, 2014
Results First Posted
July 28, 2014
Record last verified: 2014-06