Clinical Trials Logo

Clinical Trial Summary

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.


Clinical Trial Description

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00737282
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Terminated
Phase Phase 3
Start date October 2008
Completion date August 2009

See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A