A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• 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

• Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails

• Negative pregnancy test

• Agrees to Double-barrier method of contraception

• Pap smear with no evidence of malignancy or pre-malignant changes

• Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

• 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

• Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months

• History of Polycystic Ovary Syndrome or prolactinoma

• MRI shows significant gynecologic disorder

• Uterine size > 25 weeks gestation

• Hemoglobin < 8 g/dL at Day -1