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

Withdrawn before enrolling · Phase 3

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT00874302

Run by

Repros Therapeutics Inc.

People needed

0

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Other inclusion criteria may apply

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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