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

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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)

38 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Asoprisnil

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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