Clinical trial NCT00160446: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Pelvic pain
Dysmenorrhea
Dyspareunia
Infertility
Asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
timeFrame: Mean change from baseline to Months 1, 2, 3
Secondary outcomes:
measure: Global efficacy question
timeFrame: Final visit
measure: Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale
timeFrame: Each monthly visit
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References: