Reduction of menstrual blood loss by danazol in unexplained menorrhagia: lack of effect of placebo.

In women with menorrhagia of unknown cause, the efficacy of the drug danazol in reducing heavy menstrual blood loss was investigated making objective measurements of menstrual blood loss. Drug regimens tested were daily administration of 200 or 100 mg danazol for 12 weeks and daily danazol given in the luteal phase or during menstruation. The results suggest that 200 mg danazol daily is the most acceptable regimen clinically since it significantly reduced menstrual blood loss and was associated with a relatively low incidence of side effects. In 16 women on this dose menstrual blood loss was suppressed from a mean pre-treatment loss of 183 +/- 25 ml to 38 +/- 11 ml (p < 0.01) in the second, and 26 +/- 9 ml (p < 0.01) in the third treatment months. The majority of women had regular episodes of bleeding with no alteration in cycle length and a reduction in the number of days of bleeding. Although 100 mg daily suppressed menstrual blood loss, particularly by the third month of treatment, it increased the number of episodes of bleeding in some women which they found unacceptable. Both 200 mg and 100 mg relieved dysmenorrhoea in the majority of women presenting with the symptoms. Danazol taken daily in the early follicular or luteal phase of the menstrual cycle did not significantly alter menstrual blood loss. There was no effect of placebo therapy on measured menstrual blood loss in a single blind trial in eight women with menorrhagia.

RCT Entities:   Population Interventions Outcomes