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

Original Study ID : M99-110

NCT ID : NCT00160446

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

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

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.

Source : Abbott

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.

Overall Status : Completed

Start Date : May 2000

End Date : July 2001

Completion Date : July 2001

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Enrollment : 130

Verification Date : May 2008

First Received Date : September 8, 2005

Trial Eligibility

Criteria :
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

Gender : Female

Minimum Age : 18 Years

Maximum Age : 40 Years

Healthy Volunteers : No

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