Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Women With Endometriosis.
Lead Sponsor:
Abbott
Collaborating Sponsors:
Jenapharm GmbH & Co. KG
Conditions:
Endometriosis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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.
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 endometrios...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00160433
Start Date
August 1 2002
End Date
June 1 2003
Last Update
May 29 2008
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