BACKGROUND: The androgen, Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained infertility. Two randomized trials were subsequently conducted to assess the effectiveness of danazol in this population.
OBJECTIVES: The objective of this review was to assess the effects of danazol on pregnancy rates in women with unexplained subfertility.
SEARCH STRATEGY: The Cochrane Subfertility Review Group specialised register of controlled trials was searched.
SELECTION CRITERIA: Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.
DATA COLLECTION AND ANALYSIS: Data were extracted by two reviewers.
MAIN RESULTS: Two trials involving 68 women were involved. There was no difference found in pregnancy rate between danazol and placebo (odds ratio 2.57, 95% confidence 0.53 to 12.46).
REVIEWER'S CONCLUSIONS: There is not enough evidence to evaluate the effect of danazol on pregnancy rates in women with unexplained subfertility. The need to use contraception during danazol treatment, adverse effects and costs are additional considerations.