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Completed

NCT Number: NCT00160459

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

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.

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Key information

Conditions

Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asoprisnil

Drug

5 mg Tablet, oral Daily for 12 weeks

Placebo

Drug

Tablet, oral Daily for 12 weeks

Primary outcomes

  1. Percent change from baseline in uterine volume and volume of the largest fibroid.

    Time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.

  2. Duration of amenorrhea

    Time frame: Day 1 to 1st post treatment menses

Secondary outcomes

  1. Change from baseline in uterine size in gestational weeks.

    Time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6

  2. Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.

    Time frame: Week 12 and final visit

  3. Percentage of days with bleeding.

    Time frame: Day 1 through end of 1st post-treatment menses

  4. Changes in hematologic and iron parameters.

    Time frame: Baseline to each visit

  5. Uterine fibroid symptom improvement.

    Time frame: Baseline to each visit

  6. Response to Global Efficacy Question regarding improvement in fibroid symptoms.

    Time frame: Week 12 and Final Visit

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Sep 12, 2005
Registry last updated
May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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