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

May 27, 2008 updated by: Abbott

A Phase II Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of J867 Administered in Patients With Endometriosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Asoprisnil
10 mg Tablet, oral Daily for 12 weeks
Drug: Asoprisnil
25 mg Tablet, oral Daily for 12 weeks
Drug: Asoprisnil
5mg Tablet, oral Daily for 12 weeks
EXPERIMENTAL: 2
Drug: Asoprisnil
10 mg Tablet, oral Daily for 12 weeks
Drug: Asoprisnil
25 mg Tablet, oral Daily for 12 weeks
Drug: Asoprisnil
5mg Tablet, oral Daily for 12 weeks
EXPERIMENTAL: 3
Drug: Asoprisnil
10 mg Tablet, oral Daily for 12 weeks
Drug: Asoprisnil
25 mg Tablet, oral Daily for 12 weeks
Drug: Asoprisnil
5mg Tablet, oral Daily for 12 weeks
PLACEBO_COMPARATOR: 4
Drug: Placebo
Tablet, oral Daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
Time Frame: Mean change from baseline to Months 1, 2, 3
Mean change from baseline to Months 1, 2, 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Global efficacy question
Time Frame: Final visit
Final visit
Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale
Time Frame: Each monthly visit
Each monthly visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (ACTUAL)

July 1, 2001

Study Completion (ACTUAL)

July 1, 2001

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M99-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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