Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

NCT ID: NCT00874302

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

Brief Summary

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Detailed Description

Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

25 mg

25 mg Proellex

Group Type: EXPERIMENTAL

Proellex

Intervention Type: DRUG

One 25mg capsule taken orally once every day.

50 mg

50 mg Proellex

Group Type: EXPERIMENTAL

Proellex

Intervention Type: DRUG

Two 25mg capsules Proellex (50mg) taken orally once every day

Interventions

Proellex

One 25mg capsule taken orally once every day.

Intervention Type: DRUG

Proellex

Two 25mg capsules Proellex (50mg) taken orally once every day

Intervention Type: DRUG

Other Intervention Names

Telapristone acetate; Telapristone acetate

Eligibility Criteria

Inclusion Criteria

• At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
• Subject must have uterine fibroid-associated symptoms during the-screening visit
• Subject has menstrual cycle lasting from 20 to 40 days

Exclusion Criteria

• Post-menopausal women or women likely to become post-menopausal during the study
• Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
• Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
• Subject who has had an acute illness within five days of study medication administration
• Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
• Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
• Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Repros Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andre van As, MD, PhD

Role: STUDY_DIRECTOR

Repros Therapeutics Inc.

Locations

Genesis Center for Clinical Research

San Diego, California, United States

Physician Care Clinical Research, LLC

Sarasota, Florida, United States

Atlanta Women's Research Inst.

Atlanta, Georgia, United States

Soapstone Center for Clinical Research

Decatur, Georgia, United States

York Clinical Consulting

Marrero, Louisiana, United States

Female Pelvic Medicine

Grand Rapids, Michigan, United States

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, United States

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Clinical Trials of America

Eugene, Oregon, United States

Thomas Jefferson University - Jefferson Center for Women's Medical Specialties

Philadelphia, Pennsylvania, United States

Women's Care Center, PLC Research Memphis Associates

Memphis, Tennessee, United States

Meharry Medical College

Nashville, Tennessee, United States

Willowbend Health & Wellness Associates

Plano, Texas, United States

Cepeme/Cerfahc

Curitiba, Paraná, Brazil

Brazilmed

São Paulo, São Paulo, Brazil

Universidade Federal de São Paulo - UNIFESP

São Paulo, São Paulo, Brazil

Hospital dos Servidores Públicos de SP

São Paulo, São Paulo, Brazil

Hospital Heliópolis

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Vox Femina

Jundiaí, , Brazil

Countries

United States; Brazil

Other Identifiers

ZPU-306

Identifier Type: -

Identifier Source: org_study_id