Endometriosis
Conditions
Keywords
Pelvic pain, Dysmenorrhea, Dyspareunia, Infertility, Asoprisnil
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.
Interventions
DRUGAsoprisnil
5mg Tablet, oral Daily for 12 weeks
DRUGPlacebo
Tablet, oral Daily for 12 weeks
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary | Mean change from baseline to Months 1, 2, 3 |
Secondary
| Measure | Time frame |
|---|---|
| Global efficacy question | Final visit |
| Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale | Each monthly visit |
Outcome results
None listed