Status:
TERMINATED
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Detailed Description
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Eligibility Criteria
Inclusion
- Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
- Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
- Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
- Regular or steady menstrual cycle lasting from 24 to 36 days
- Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
- Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug
Exclusion
- Documented endometriosis or active pelvic inflammatory disease
- History of alcohol and/or drug abuse
- Any history or diagnosis of gynecological cancer or cervical dysplasia
- Use of an IUD
- Use of prohibited concomitant medications:
- Use of Depo-Provera must cease 10 months prior to first dose of study drug
- Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
- Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00683917
Start Date
May 1 2008
End Date
August 1 2009
Last Update
August 21 2014
Active Locations (4)
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1
Physician Care Clinical Research
Sarasota, Florida, United States, 34239
2
Advances in Health, Inc.
Houston, Texas, United States, 77030
3
West Houston Clinical Research Services
Houston, Texas, United States, 77055
4
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)
Mexico City, Federal District, Mexico, 03100