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Completed

NCT Number: NCT00156208

Safety of Treatment of Uterine Fibroids With Asoprisnil

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

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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 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 long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
  • Otherwise good health
  • Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
  • Agrees to double-barrier method of contraception
  • Adequate endometrial biopsy with no significant histological disorder

Exclusion criteria

  • Any abnormal lab or procedure result(s) the study-doctor considers important
  • History of a blood-clotting disorder
  • Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away
  • Significant gynecological disorder, such as endometrial polyp

Treatment and study plan

Asoprisnil

Drug

10mg Tablet, oral Daily for 18 months

Other names: J867

Primary outcomes

  1. Long Term Safety

    Time frame: Throughout 18 month treatment period

Secondary outcomes

  1. Cumulative and incremental amenorrhea rates.

    Time frame: Each month 1-18

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

    Time frame: Final Visit

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

    Time frame: Final Visit

  4. Change from baseline in Uterine Fibroid Impact Questionnaire.

    Time frame: Months 6, 12, 18

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

    Time frame: Final Visit

  6. Change from baseline in the two dimensions of the SF-36.

    Time frame: Final Visit

  7. Change from baseline in the monthly bleeding score.

    Time frame: Final Month

  8. Change from baseline in the hemoglobin concentration.

    Time frame: Final Visit

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

    Time frame: Final Visit

  10. Percentage of subjects who discontinue with the intent to have surgery for fibroids.

    Time frame: During Treatment Period

  11. Percentage of subjects who responded positively to the Global Efficacy Questions.

    Time frame: Months 6, 12, 18

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
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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