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Completed

NCT Number: NCT00160420

A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398

The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.

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Key information

Conditions

Endometriosis Dysmenorrhea Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Infertility Male Urogenital Diseases Menstruation Disturbances Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and 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 3 months of dosing and Month 3 procedures in study M01-398
  • Otherwise in good health
  • Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder

Exclusion criteria

  • Any abnormal lab or procedure result the study-doctor considers important
  • Anticipated need for excluded hormonal therapy or unapproved narcotics

Treatment and study plan

Asoprisnil

Drug

5mg Tablet, oral Daily for 12 months

Primary outcomes

  1. Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.

    Time frame: Months 1,3,6,9,12 and final visit

  2. Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.

    Time frame: Months 3,6,9,12 and final visit

Secondary outcomes

  1. Percentage of subjects with amenorrhea.

    Time frame: Throught treatment period.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
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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