Crossover Study of the Safety and PK Properties of Proellex®
Completed · Phase 1
Conditions studied: Pharmacokinetics
In brief
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
Key facts
- Study ID
- NCT00749879
- Run by
- Repros Therapeutics Inc.
- People needed
- 17
- Starts
- 2008-08-11
- Expected to finish
- 2008-10-23
- Last updated by the study team
- 2019-04-29
Who can join
Age: 18 and older, up to 34. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
- Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
- Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
- Must have a negative urine pregnancy test at screening
- Able to swallow gelatin capsules
- Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
- Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
- Other inclusion criteria may apply
You may not qualify if…
- Symptomatic uterine fibroids or endometriosis
- Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
- Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
- Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
- Other exclusion criteria may apply
Where it is running
- Healthcare Discoveries Inc. — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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