A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

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Abbott

Status and phase

Completed
Phase 3

Conditions

Metrorrhagia
Fibroid Uterus
Uterine Fibroids
Leiomyoma
Menorrhagia

Treatments

Drug: Asoprisnil
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152256
C02-037

Details and patient eligibility

About

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

Full description

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Enrollment

239 patients

Sex

Female

Ages

18 to 53 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Premenopausal women
  • History of regular menstrual cycles (21-42 days)
  • Diagnosis of uterine fibroid(s)
  • Abnormal vaginal bleeding associated with uterine fibroids
  • Otherwise in good health
  • Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3

Exclusion criteria

  • Less than 3 months postpartum and post-lactation
  • Previous myomectomy within 1 year
  • Any abnormal lab or procedure result the study-doctor considers important
  • Severe reaction(s) to or are currently using any hormone therapy
  • History of osteoporosis or other bone disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

239 participants in 3 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Asoprisnil
2
Experimental group
Treatment:
Drug: Asoprisnil
3
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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