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

Information source: Repros Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Fibroids

Intervention: Proellex 25 mg (Drug); Proellex 50 mg (Drug); Lupron Depot (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Repros Therapeutics Inc.

Official(s) and/or principal investigator(s):
Andre vanAs, MD, PhD, Study Director, Affiliation: Repros Therapeutics Inc.

Summary

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

Clinical Details

Official title: A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma), Mexico City, Federal District 03100, Mexico

Physician Care Clinical Research, Sarasota, Florida 34239, United States

Advances in Health, Inc., Houston, Texas 77030, United States

West Houston Clinical Research Services, Houston, Texas 77055, United States

Additional Information

Starting date: May 2008
Last updated: August 5, 2014

Page last updated: August 23, 2015

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