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Completed

NCT Number: NCT00152256

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

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.

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Key information

Conditions

Fibroid Uterus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Menorrhagia Menstruation Disturbances Metrorrhagia Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Fibroids Uterine Hemorrhage

Age range

18 year–53 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Asoprisnil

Drug

Asoprisnil 10 mg Tablet, oral Daily for 6 months

Other names: J867

Placebo

Drug

Placebo Tablet, oral Daily for 6 months

Primary outcomes

  1. Cumulative percent of subjects achieving amenorrhea.

    Time frame: Month 3

Secondary outcomes

  1. Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.

    Time frame: Final Visit

  2. Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.

    Time frame: Final Visit

  3. Change from baseline in the Work Limitation Questionnaire Index.

    Time frame: Final Visit

  4. Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).

    Time frame: Final Visit

  5. Change from baseline in the monthly bleeding score.

    Time frame: Final Visit

  6. Change from baseline in the hemoglobin concentration.

    Time frame: Final Visit

  7. Change from baseline in volume of the largest fibroid.

    Time frame: Final Visit

  8. Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.

    Time frame: During treatment period

  9. Percentage of subjects who respond positively to the global efficacy question.

    Time frame: Final Visit

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 9, 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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