A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Abbott

Status and phase: Completed; Phase 2

Conditions: Leiomyoma

Treatments: Drug: Asoprisnil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160459

M99-144

Details and patient eligibility

About

This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

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 safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Enrollment: 129 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women between 18 and 49 years of age
• Diagnosis of either 1 or more uterine fibroids
• History of regular menstrual cycles of 21 to 35 days in length.

Exclusion criteria

• Any abnormal lab result the study-doctor considers significant
• History of severe reaction to or current use of hormone therapy
• History of osteoporosis or other bone disease
• History of uterine artery embolization, cryomyolysis, or electrical myolysis
• Subject currently breast feeding
• Hemoglobin < 8 g/dL at baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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129 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Asoprisnil

Drug: Asoprisnil

Drug: Asoprisnil

2

Experimental group

Treatment:

Drug: Asoprisnil

Drug: Asoprisnil

Drug: Asoprisnil

3

Experimental group

Treatment:

Drug: Asoprisnil

Drug: Asoprisnil

Drug: Asoprisnil

4

Placebo Comparator group

Treatment:

Drug: Placebo