A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

NCT00152256 | Completed Phase 3 DMC

• 1 other identifier: C02-037
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

Conditions

Fibroid Uterus; Leiomyoma; Menorrhagia; Metrorrhagia; Uterine Fibroids

Keywords

Symptomatic Uterine Fibroids; Excessive Uterine Bleeding; Uterine Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Cumulative percent of subjects achieving amenorrhea.

  Month 3

Secondary Outcomes (9)

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

  Final Visit

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

  Final Visit

• Change from baseline in the Work Limitation Questionnaire Index.

  Final Visit

• Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).

  Final Visit

• Change from baseline in the monthly bleeding score.

  Final Visit

Study Arms (3)

1

EXPERIMENTAL

Drug: Asoprisnil

2

EXPERIMENTAL

Drug: Asoprisnil

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Asoprisnil DRUG

Asoprisnil 10 mg Tablet, oral Daily for 6 months

Also known as: J867

1

Placebo DRUG

Placebo Tablet, oral Daily for 6 months

3

Eligibility Criteria

• Age: 18 Years - 53 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3

You may not qualify if:

• Less than 3 months postpartum and post-lactation
• Previous myomectomy within 1 year
• 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

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Leiomyoma; Menorrhagia; Metrorrhagia; Uterine Hemorrhage

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Medical Director

  Abbott

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2003
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: May 29, 2008

Record last verified: 2008-05