- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01187043
Determination of the Lowest, Safe and Effective Dose of Proellex
June 27, 2014 updated by: Repros Therapeutics Inc.
A Single-Blind, Placebo Run-in, Phase I/II Study Comparing Five Oral Doses of Proellex®
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.
Study Overview
Detailed Description
A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching placebo in healthy adult female subjects of reproductive age.
Exposure to study drug will be for up to 10 weeks.
In-clinic pharmacokinetic (PK) assessments will be made on the first day of dosing and on the last day (week 10).
Office visits will occur every week to assess liver function and trough blood concentrations for Proellex and primary metabolite.
Daily vaginal bleeding diaries will be maintained during the course of the study.
A single blind run-in period of up to 56 days will begin the study to assess baseline menstrual patterns will be utilized.
Twelve subjects per treatment group (total 60 subjects) will be assigned to each dose.
New groups will not begin dosing until the previous dose group has completed.
Daily treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex.
A single blind run-in period using placebo will be incorporated to establish baseline parameters.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78209
- ICON Devlopment Solutions
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARM 1
1 mg Proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Other Names:
|
Experimental: ARM 2
3 mg Proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Other Names:
|
Experimental: ARM 3
6 mg Proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Other Names:
|
Experimental: ARM 4
9 mg Proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Other Names:
|
Experimental: ARM 5
12 mg proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Induction Amenorrhea
Time Frame: 10 weeks
|
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.
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10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura M Sterling, MD, ICON Development Solutions
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 20, 2010
First Submitted That Met QC Criteria
August 20, 2010
First Posted (Estimate)
August 23, 2010
Study Record Updates
Last Update Posted (Estimate)
July 28, 2014
Last Update Submitted That Met QC Criteria
June 27, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZP-204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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