Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Stopped early · Phase 2

Conditions studied: Uterine Fibroids

In brief

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Key facts

Study ID: NCT00683917
Run by: Repros Therapeutics Inc.
People needed: 10
Starts: 2008-05-01
Expected to finish: 2009-08-01
Last updated by the study team: 2014-08-21

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Physician Care Clinical Research — Sarasota, Florida, United States
Advances in Health, Inc. — Houston, Texas, United States
West Houston Clinical Research Services — Houston, Texas, United States
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma) — Mexico City, Federal District, Mexico

Full record on ClinicalTrials.gov

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