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Completed

NCT Number: NCT00152269

Treatment of Uterine Fibroids With Asoprisnil(J867)

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

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Key information

Conditions

Leiomyoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage 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 Hemorrhage

Age range

18 year and older

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 in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

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
  • Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
  • Negative pregnancy test
  • Agrees to Double-barrier method of contraception
  • Pap smear with no evidence of malignancy or pre-malignant changes
  • Endometrial biopsy with no significant histological disorder

Exclusion criteria

  • 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
  • Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
  • History of Polycystic Ovary Syndrome or prolactinoma
  • MRI shows significant gynecologic disorder
  • Uterine size > 25 weeks gestation
  • Hemoglobin < 8 g/dL at Day -1

Treatment and study plan

Asoprisnil

Drug

10mg Tablet, oral Daily for 12 months

Placebo

Drug

Placebo, Tablet, oral Daily for 12 months

Primary outcomes

  1. The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.

    Time frame: Month 12 or Final Visit

Secondary outcomes

  1. Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.

    Time frame: Month 6

  2. Change from baseline in menstrual pictogram score.

    Time frame: Final Month

  3. Change from baseline in number of days with bleeding.

    Time frame: Final Month

  4. Change from baseline in hemoglobin concentration.

    Time frame: Final Visit

  5. Percent change from baseline in volume of the largest fibroid.

    Time frame: Final Visit

  6. Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.

    Time frame: Final Visit

  7. Change from baseline in total symptom severity score and UFS-QOL total score.

    Time frame: Final Visit

  8. Cumulative percent of subjects who achieve amenorrhea.

    Time frame: Month 3

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata

Important dates

Study start
2002
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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