Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

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

Details

• Lead Sponsor: Bayer
• Treatments: Dienogest; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Nandrolone; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Women 18 years or older

• And with a diagnosis of dysfunctional uterine bleeding without organic pathology

• And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

• The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.

• Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.