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Completed

NCT Number: NCT00156195

Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

The objective of this study is to determine the long-term safety of asoprisnil in 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 long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

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 who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
  • Otherwise in good health
  • Premenopausal based on Estrogen and FSH levels
  • Agrees to use of 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
  • Significant gynecological disorder such as confirmed endometrial polyp
  • Hemoglobin < 8.0 g/dL
  • 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.

Treatment and study plan

Asoprisnil

Drug

10 mg Tablet, oral Daily for 12 months

Primary outcomes

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

    Time frame: Month 12

Secondary outcomes

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

    Time frame: Month 6

  2. Change from baseline in menstrual pictogram bleeding score.

    Time frame: Final Month

  3. Change from baseline in the 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 the 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 the Uterine Fibroid Symptom-Quality of Life total score.

    Time frame: Final Visit

  8. Cumulative percent of subjects who achieve amenorrhea.

    Time frame: Each Month

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
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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