Uterine Fibroids Clinical Trial
Official title:
A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
No medical therapy is currently available for the long-term treatment of abnormal uterine
bleeding associated with uterine fibroids in women and many women must resort to surgery for
relief. The objective of this study is to determine the long-term safety of asoprisnil 10
and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata
who completed the 6 month Study C02-037. The safety endpoints for this study will be based
on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and
clinical laboratory evaluations.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was
prematurely discontinued for all subjects. To ensure safety, subjects will remain on study
and will undergo scheduled study procedures. In most subjects, endometrial changes reversed
after asoprisnil discontinuation.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), 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| Withdrawn |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 |
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| Withdrawn |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 | |
| 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 |