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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00160446

Purpose

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.

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

MedlinePlus related topics: Endometriosis Female Sexual Dysfunction Pelvic Pain

Drug Information available for: Asoprisnil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of J867 Administered in Patients With Endometriosis

Further study details as provided by Abbott:

Primary Outcome Measures:

Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary [ Time Frame: Mean change from baseline to Months 1, 2, 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global efficacy question [ Time Frame: Final visit ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	130
Study Start Date:	May 2000
Study Completion Date:	July 2001
Primary Completion Date:	July 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Asoprisnil 5mg Tablet, oral Daily for 12 weeks
2: Experimental	Drug: Asoprisnil 10 mg Tablet, oral Daily for 12 weeks
3: Experimental	Drug: Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
4: Placebo Comparator	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 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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160446

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Medical Director

Abbott

More Information

Responsible Party:	Abbott ( Cynthia Mattia-Goldberg )
Study ID Numbers:	M99-110
Study First Received:	September 8, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00160446
Health Authority:	United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Abbott:

Pelvic pain
Dysmenorrhea
Dyspareunia
Infertility
Asoprisnil

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Pelvic Pain
Dysmenorrhea

Endometriosis
Pain
Dyspareunia

ClinicalTrials.gov processed this record on January 16, 2009