Uterine Fibroids Clinical Trial
Official title:
A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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| Withdrawn |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 |
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 | |
| Completed |
NCT01631903 -
Extension of Study 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| Withdrawn |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 | |
| 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 | |
| Terminated |
NCT01555073 -
Preemptive Analgesia Following Uterine Artery Embolization
|
Phase 4 | |
| Completed |
NCT01452659 -
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
|
Phase 2 | |
| Completed |
NCT01229826 -
Magnetic Resonance Elastography (MRE) of Uterine Fibroids
|
N/A | |
| Terminated |
NCT00785356 -
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
|
Phase 3 |