MedDataX Logo

A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

NCT ID: NCT00152256

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Symptomatic Uterine Fibroids Excessive Uterine Bleeding Uterine Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

Asoprisnil 10 mg Tablet, oral Daily for 6 months

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

Asoprisnil 25mg Tablet, oral Daily for 6 months

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Tablet, oral Daily for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Asoprisnil

Asoprisnil 10 mg Tablet, oral Daily for 6 months

Intervention Type DRUG

Asoprisnil

Asoprisnil 25mg Tablet, oral Daily for 6 months

Intervention Type DRUG

Placebo

Placebo Tablet, oral Daily for 6 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

J867 J867

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

53 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abbott

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_CHAIR

Abbott

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C02-037

Identifier Type: -

Identifier Source: org_study_id