Status:
TERMINATED
Study to Evaluate Menses Induction in Women Administered Proellex
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Amenorrhea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Detailed Description
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00881608
Start Date
February 1 2009
End Date
August 1 2009
Last Update
August 25 2014
Active Locations (1)
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1
Advances in Health Inc.
Houston, Texas, United States, 77030