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

Sponsor:	Abbott
Collaborator:	Jenapharm GmbH & Co. KG
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00160433

Purpose

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.

Condition	Intervention	Phase
Endometriosis	Drug: Asoprisnil Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis Pelvic Pain Sexual Problems in Women

Drug Information available for: Asoprisnil

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Mean change from baseline in pelvic pain as assessed by daily diary [ Time Frame: Final month ] [ Designated as safety issue: No ]
Mean change from baseline in dysmenorrhea as assessed by daily diary [ Time Frame: Final month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary. [ Time Frame: Months 1,2,3 and Months 1-3 ] [ Designated as safety issue: No ]
Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary. [ Time Frame: Months 1,2,3 and Months 1-3 and the Final Month ] [ Designated as safety issue: No ]
Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary. [ Time Frame: Months 1,2,3 and Months 1-3 and Final Month ] [ Designated as safety issue: No ]
Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale. [ Time Frame: Months 1,2,3 and Final Visit ] [ Designated as safety issue: No ]
Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale. [ Time Frame: Months 1,2,3 and Final Visit ] [ Designated as safety issue: No ]
Percent of subjects with "Yes" response to Global Efficacy question. [ Time Frame: Months 1,2,3 and Final Visit ] [ Designated as safety issue: No ]
Change from baseline in analgesic use scores. [ Time Frame: Months 1,2,3, Months 1-3 and Final Visit ] [ Designated as safety issue: No ]
Percent of subjects who achieve amenorrhea. [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
Change from baseline in Endometriosis Health Profile-30 (EHP-30) scores. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Change from baseline in Short Form-36 scores. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Change from baseline in both monthly bleeding scores and percentage of days with bleeding or spotting. [ Time Frame: Months 1-3 ] [ Designated as safety issue: No ]
Change from Screening menses in bleeding intensity. [ Time Frame: First post-treatment menses ] [ Designated as safety issue: No ]
Change from baseline in hemoglobin and hematocrit. [ Time Frame: Months 1,2,3 and Final Visit ] [ Designated as safety issue: No ]

Enrollment:	131
Study Start Date:	August 2002
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Asoprisnil 0.5 mg Tablet, oral Daily for 12 weeks
Experimental: 2	Drug: Asoprisnil 1.5 mg Tablet, oral Daily for 12 weeks
Experimental: 3	Drug: Asoprisnil 5.0 mg Tablet, oral Daily for 12 weeks
Placebo Comparator: 4	Drug: Placebo Tablet, oral Daily for 12 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160433

Sponsors and Collaborators

Abbott

Jenapharm GmbH & Co. KG

Investigators

Study Chair:

Medical Director

Abbott

More Information

No publications provided

Responsible Party:	Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier:	NCT00160433 History of Changes
Other Study ID Numbers:	M01-398
Study First Received:	September 8, 2005
Last Updated:	May 27, 2008
Health Authority:	United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:

Pelvic pain
Dysmenorrhea
Dyspareunia
Infertility
asoprisnil

Additional relevant MeSH terms:

Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012