Status: Currently recruiting patients in U.S.
Purpose:
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Safety will be assessed throughout the study.
Eligibility:
Females, ages 18 years to 34 years
Inclusion Criteria:
- Subject must be able to speak, read and understand English and be willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures.
- Premenopausal women 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
- In general good health
- Additional inclusion criteria may apply
Exclusion Criteria:
- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study
- Past or present history of experiencing any allergic reaction to the formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
- Any medical condition, which, in the judgment of the Principal Investigator, will prevent the subject from starting and/or completing the study
- Past or present history of any significant cardiovascular, renal, hepatic disease, thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring ongoing medical therapy or clinical intervention
- A QTc interval of >450ms at screening
- Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
- Subjects with symptomatic uterine fibroids or endometriosis
- Additional exclusion criteria may apply
Study Drug:
Proellex 25 mg capsules, Formulation A
Proellex 25 mg capsules, Formulation B, Fed
Proellex 25 mg capsules, Formulation B, Fasting
Study Design:
Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Primary Outcome Measures:
To determine and compare the pharmacokinetic (PK) properties of a single dose of Proellex® (25 mg) using two different formulations of the drug in healthy adult female subjects with or without fasting [:hours]
Secondary Outcome Measures:
To determine and compare the safety of a single dose of Proellex® (25 mg) using two formulations of the drug in healthy adult female subjects with or without fasting
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Study Director:
Andre van As, MD, PhD
Repros Therapeutics Inc.
If you meet the study criteria and are interested in participating in the study, please contact:
Study Managers:
John Weiler, MD
319-626-8888
jweiler@compleware.com
Michelle Moore
319-626-8888
mmoore@compleware.com
Current Clinical Site Locations:
*Recruiting
Healthcare Discoveries Inc.
San Antonio, Texas, 78209
Contact: Angela Jeter
210-225-5423
ajeter@hcd-inc.com
For more information, please visit www.clinicaltrials.gov
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