A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398 - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00160420

Purpose

The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.

Condition	Intervention	Phase
Endometriosis	Drug: Asoprisnil	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, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis

Further study details as provided by Abbott:

Primary Outcome Measures:

Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale. [ Time Frame: Months 1,3,6,9,12 and final visit ] [ Designated as safety issue: No ]
Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale. [ Time Frame: Months 3,6,9,12 and final visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects with amenorrhea. [ Time Frame: Throught treatment period. ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	December 2002
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Asoprisnil 5mg Tablet, oral Daily for 12 months

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 long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The 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:

Completed 3 months of dosing and Month 3 procedures in study M01-398
Otherwise in good health
Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder

Exclusion Criteria:

Any abnormal lab or procedure result the study-doctor considers important
Anticipated need for excluded hormonal therapy or unapproved narcotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160420

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Medical Director

Abbott

More Information

Responsible Party:	Abbott ( Cynthia Mattia-Goldberg )
Study ID Numbers:	M02-408
Study First Received:	September 8, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00160420
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

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