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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00160446

Collaborator

(none)

130

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Asoprisnil Drug: Asoprisnil Drug: Asoprisnil Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Jul 1, 2001

Actual Study Completion Date :

Jul 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil 5mg Tablet, oral Daily for 12 weeks
Experimental: 2	Drug: Asoprisnil 10 mg Tablet, oral Daily for 12 weeks
Experimental: 3	Drug: Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
Placebo Comparator: 4	Drug: Placebo Tablet, oral Daily for 12 weeks

Outcome Measures

Primary Outcome Measures

Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary [Mean change from baseline to Months 1, 2, 3]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

moderate or severe pelvic pain not related to menstruation, OR
moderate or severe dysmenorrhea, OR
moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain.