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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00160433

Collaborator

Jenapharm GmbH & Co. KG (Other)

131

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase II, 3-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Doses of J867 (0.5, 1.5 and 5 mg QD) Versus Placebo in Subjects With Endometriosis

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil 0.5 mg Tablet, oral Daily for 12 weeks
Experimental: 2	Drug: Asoprisnil 1.5 mg Tablet, oral Daily for 12 weeks
Experimental: 3	Drug: Asoprisnil 5.0 mg Tablet, oral Daily for 12 weeks
Placebo Comparator: 4	Drug: Placebo Tablet, oral Daily for 12 weeks

Outcome Measures

Primary Outcome Measures

Mean change from baseline in pelvic pain as assessed by daily diary [Final month]
Mean change from baseline in dysmenorrhea as assessed by daily diary [Final month]

Secondary Outcome Measures

Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary. [Months 1,2,3 and Months 1-3]
Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary. [Months 1,2,3 and Months 1-3 and the Final Month]
Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary. [Months 1,2,3 and Months 1-3 and Final Month]
Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale. [Months 1,2,3 and Final Visit]
Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale. [Months 1,2,3 and Final Visit]
Percent of subjects with "Yes" response to Global Efficacy question. [Months 1,2,3 and Final Visit]
Change from baseline in analgesic use scores. [Months 1,2,3, Months 1-3 and Final Visit]
Percent of subjects who achieve amenorrhea. [Throughout the treatment period]
Change from baseline in Endometriosis Health Profile-30 (EHP-30) scores. [Month 3]
Change from baseline in Short Form-36 scores. [Month 3]
Change from baseline in both monthly bleeding scores and percentage of days with bleeding or spotting. [Months 1-3]
Change from Screening menses in bleeding intensity. [First post-treatment menses]
Change from baseline in hemoglobin and hematocrit. [Months 1,2,3 and Final Visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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