Background: Uterine fibroids (myomas, fibromyomas, leiomyomas) are the most common benign tumours of the female genital tract. Danazol, a synthetic isoxazole derivative chemically related to 17-ethinyl testosterone, has been used for many years for the treatment of women with uterine fibroids.
Objectives: To evaluate the effectiveness and safety of danazol in women with uterine fibroids.
Search strategy: We searched the Cochrane Menstrual Disorders and Subfertility Review Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4); MEDLINE; EMBASE; Chinese Biomedical Disc; and the China National Knowledge Infrastructure for relevant trials (to December 2008). Attempts were made to identify trials from references in published studies. We also searched for ongoing trials in the five major clinical trials registries.
Selection criteria: Randomised controlled trials of danazol versus placebo or any other medical therapy in women with uterine fibroids confirmed by medical procedures, regardless of the women's symptoms or age. Women with malignancies were excluded.
Data collection and analysis: Data extraction and risk of bias assessment were not been performed because there were no identified studies.
Main results: We did not identify any studies which met our full inclusion criteria.
Authors' conclusions: There is no reliable evidence available from randomised controlled trials regarding the benefits and or harms of the use of danazol for treating uterine fibroids.