Overview

Treatment of Uterine Fibroids With Asoprisnil(J867)

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