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

NCT ID: NCT00160433

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-06-30

Brief Summary

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The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.

Detailed Description

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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 if a dose-response relationship exists between asoprisnil and endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with endometriosis. Women with surgically confirmed endometriosis will be administered asoprisnil 0.5, 1.5, and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed by improvement in pelvic pain, dysmenorrhea, dyspareunia, bleeding, analgesic use, global efficacy, and quality of life questionnaires. Safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Conditions

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Endometriosis

Keywords

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Pelvic pain Dysmenorrhea Dyspareunia Infertility asoprisnil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

0.5 mg Tablet, oral Daily for 12 weeks

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

1.5 mg Tablet, oral Daily for 12 weeks

3

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

5.0 mg Tablet, oral Daily for 12 weeks

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, oral Daily for 12 weeks

Interventions

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Asoprisnil

0.5 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

1.5 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

5.0 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Placebo

Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women (18-40 years)
* Surgically confirmed endometriosis within 3 years
* History of menstrual cycles between 21 and 35 days
* Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain
* Negative pregnancy test
* Agrees to use double barrier method of contraception
* Pap smear with no evidence of malignancy or pre-malignant changes
* Ultrasound with no significant gynecological disorder.
* Otherwise in good health

Exclusion Criteria

* Less than 3 months after having a baby or breast-feeding
* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to hormone therapy
* Anticipated need for excluded hormonal therapy or unapproved narcotics
* Current use of an IUD
* History or prolactinoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jenapharm GmbH & Co. KG

UNKNOWN

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Medical Director

Role: STUDY_CHAIR

Abbott

Other Identifiers

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M01-398

Identifier Type: -

Identifier Source: org_study_id