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

Abbott

Status and phase: Completed; Phase 2

Conditions: Leiomyoma

Treatments: Drug: Asoprisnil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00156182

M01-275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Asoprisnil