MedDataX Logo

A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis

NCT ID: NCT00160446

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

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2001-07-31

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 effectiveness of three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.

Detailed Description

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

Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the safety and efficacy of asoprisnil 5, 10, and 25 mg tablets, compared to placebo, administered daily for 12 weeks to women with endometriosis, by assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea, dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens the subjects' perceived pain symptoms. Otherwise healthy women with surgically confirmed endometriosis will be enrolled.

Conditions

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

Endometriosis

Keywords

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

Pelvic pain Dysmenorrhea Dyspareunia Infertility Asoprisnil

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

5mg Tablet, oral Daily for 12 weeks

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

10 mg Tablet, oral Daily for 12 weeks

3

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

25 mg Tablet, oral Daily for 12 weeks

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, oral Daily for 12 weeks

Interventions

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

Asoprisnil

5mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

10 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

25 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Placebo

Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Surgically confirmed endometriosis
* History of menstrual cycles between 26 and 32 days
* Otherwise in good health
* Age 18-40 years, inclusive
* Subject had pain graded at Screening and Day 1 according to a scale suggested by Biberoglu and Berhman5 in at least one of the following categories:

1. moderate or severe pelvic pain not related to menstruation, OR
2. moderate or severe dysmenorrhea, OR
3. moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain.
* Subject agrees to double barrier method of contraception

Exclusion Criteria

* Any abnormal lab or procedure result the study-doctor considers important
* History of undiagnosed uterine bleeding or gynecological disorder
* Severe reaction(s) to hormone therapy
* History of osteoporosis or other metabolic bone disease
* Subject currently breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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.

M99-110

Identifier Type: -

Identifier Source: org_study_id