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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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