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

Original Study ID : M01-398

NCT ID : NCT00160433

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

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

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.

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 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.

Overall Status : Completed

Start Date : August 2002

End Date : June 2003

Completion Date : June 2003

Official Title : Phase 2

Phase : Interventional

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

Enrollment : 131

Verification Date : May 2008

First Received Date : September 8, 2005

Trial Eligibility

Criteria :
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

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 Asoprisnil in the Treatment of Women With Endometriosis.