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Completed

NCT Number: NCT00156182

A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

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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 long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Completed dosing and Day 84 procedures at sites in study M99-144
  • No interruption of dosing
  • Otherwise continued good health

Exclusion criteria

  • Any abnormal lab result the study-doctor considers significant
  • History of severe reaction to or current use of hormone therapy
  • History of alcohol or drug abuse

Treatment and study plan

Asoprisnil

Drug

10mg Tablet, oral Daily for 6 months

Primary outcomes

  1. Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144

    Time frame: Treatment months 3 and 6 and Post-treatment months 3 and 6

  2. Percentage of subjects that achieved amenorrhea.

    Time frame: Treatment months 1-6

Secondary outcomes

  1. Improvement in hematologic parameters.

    Time frame: Treatment months 2,4,and 6

  2. Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale

    Time frame: Treatment Months 1-6

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

    Time frame: Months 3 and 6

  4. Duration of amenorrhea.

    Time frame: Start of previous study to first post-treatment menses.

  5. Response to global efficacy question regarding improvement of fibroid symptoms.

    Time frame: Month 6

  6. Mean change from baseline for endocrine determinations.

    Time frame: Months 2,4 and 6

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Sep 12, 2005
Registry last updated
Mar 4, 2009

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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