A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids. - Full Text View

Purpose

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

Condition	Intervention	Phase
Leiomyoma	Drug: Asoprisnil	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Further study details as provided by Abbott:

Primary Outcome Measures:

Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144 [ Time Frame: Treatment months 3 and 6 and Post-treatment months 3 and 6 ] [ Designated as safety issue: No ]
Percentage of subjects that achieved amenorrhea. [ Time Frame: Treatment months 1-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in hematologic parameters. [ Time Frame: Treatment months 2,4,and 6 ] [ Designated as safety issue: Yes ]
Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale [ Time Frame: Treatment Months 1-6 ] [ Designated as safety issue: No ]
Change from baseline in uterine size in gestational weeks. [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
Duration of amenorrhea. [ Time Frame: Start of previous study to first post-treatment menses. ] [ Designated as safety issue: No ]
Response to global efficacy question regarding improvement of fibroid symptoms. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Mean change from baseline for endocrine determinations. [ Time Frame: Months 2,4 and 6 ] [ Designated as safety issue: Yes ]

Enrollment:	38
Study Start Date:	April 2001
Study Completion Date:	December 2001
Primary Completion Date:	December 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Asoprisnil 10mg Tablet, oral Daily for 6 months

Detailed Description:

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completed dosing and Day 84 procedures at sites in study M99-144
No interruption of dosing
Otherwise continued good health

Exclusion Criteria:

Any abnormal lab result the study-doctor considers significant
History of severe reaction to or current use of hormone therapy
History of alcohol or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156182

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Medical Director

Abbott

More Information

No publications provided

Responsible Party:	Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier:	NCT00156182 History of Changes
Other Study ID Numbers:	M01-275
Study First Received:	September 7, 2005
Last Updated:	March 3, 2009
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Abbott:

Fibroid Uterus
Leiomyoma
Uterine Fibroids
asoprisnil

Additional relevant MeSH terms:

Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 17, 2013