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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00152256
Other study ID # C02-037
Secondary ID
Status Completed
Phase Phase 3
First received September 7, 2005
Last updated May 27, 2008
Start date September 2003
Est. completion date February 2005

Study information

Verified date May 2008
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 239
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 53 Years
Eligibility Inclusion Criteria:

- Premenopausal women

- History of regular menstrual cycles (21-42 days)

- Diagnosis of uterine fibroid(s)

- Abnormal vaginal bleeding associated with uterine fibroids

- Otherwise in good health

- Subject must have at least one fibroid with a diameter = 2 cm or multiple small fibroids with a uterine volume of = 200 cm3

Exclusion Criteria:

- Less than 3 months postpartum and post-lactation

- Previous myomectomy within 1 year

- Any abnormal lab or procedure result the study-doctor considers important

- Severe reaction(s) to or are currently using any hormone therapy

- History of osteoporosis or other bone disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for 6 months
Asoprisnil
Asoprisnil 25mg Tablet, oral Daily for 6 months
Placebo
Placebo Tablet, oral Daily for 6 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative percent of subjects achieving amenorrhea. Month 3 No
Secondary Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. Final Visit No
Secondary Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. Final Visit No
Secondary Change from baseline in the Work Limitation Questionnaire Index. Final Visit No
Secondary Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary). Final Visit No
Secondary Change from baseline in the monthly bleeding score. Final Visit No
Secondary Change from baseline in the hemoglobin concentration. Final Visit No
Secondary Change from baseline in volume of the largest fibroid. Final Visit No
Secondary Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment. During treatment period No
Secondary Percentage of subjects who respond positively to the global efficacy question. Final Visit No
See also
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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
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
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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