Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Desogestrel; Dienogest; Goserelin; Nandrolone

Criteria

Inclusion Criteria:

• Women with 35 - 55 years of age

• Uterine volume between 50cc and 500cc

• Abnormal uterine bleeding probably associated to intramural uterine leiomyomas

Exclusion Criteria:

• Pregnancy

• Liver or kidney dysfunction

• Women with only submucosal or subserosal uterine leiomyomas

• Women with contraindications to any of the drugs (categories 3 and 4 of WHO eligibility criteria)

• Use of anticoagulants

• Others causes of abnormal uterine bleeding (endometrial pathology, cervical pathology)