A Phase 2 interventional study of Asoprisnil and Asoprisnil in Endometriosis, sponsored by Abbott. Completed. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2008-05-29.
Sponsored by Abbott · Phase 2, Interventional, and Treatment
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.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 130 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Drug: Asoprisnil
Drug: Asoprisnil
Drug: Asoprisnil
Drug: Placebo
5mg Tablet, oral Daily for 12 weeks
10 mg Tablet, oral Daily for 12 weeks
25 mg Tablet, oral Daily for 12 weeks
Tablet, oral Daily for 12 weeks
Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
Time frame: Mean change from baseline to Months 1, 2, 3
Global efficacy question
Time frame: Final visit
Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale
Time frame: Each monthly visit
No study locations are listed for this record.
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abbott