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

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00683917
• Other study ID #: ZPU-202
• Status: Terminated
• Phase: Phase 2
• First received: May 22, 2008
• Last updated: August 5, 2014
• Start date: May 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex 25 mg
Proellex 25 mg, 1 capsule daily for 4 months
• Proellex 50 mg
Proellex 50 mg, 2 capsules daily for 4 months
• Lupron Depot
Lupron 3.75 mg monthly intramuscular injections for 4 months

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.		4 months	Yes