Danazol in menorrhagia: a double blind placebo controlled trial

Summary

In a double blind study danazol was compared with placebo in the treatment of symptomatic primary menorrhagia. Seventy-six patients were assigned at random either danazol 200 mg daily or a matching placebo for 3 months. with subsequent observation for up to 6 months. Menstmation was assessed subjectively. Significant improvement, which was maintained for up to 4 months after treatment, was seen only with danazol. No serious side effects were encountered, although relatively minor symptomatic complaints interrupted danazol treatment in five patients and placebo in one. This study confirms that danazol 200 mg daily is effective in controlling symptomatic primary menorrhagia. A 3 month course has a 'carry over' effect which appears to be clinically useful.

Danazol. a 2, 3 isoxazole derivative of 17-ethinyl testosterone, is an accepted treatment for endomet-riosis (Greenblatt et al., 1971; Luciano, 1982) and is known to suppress menstrual bleeding. Its value in the treatment of primary menorrhagia defined by blood loss exceeding 80 ml per month has been reported. In previous studies it was found that a 3 month course of danazol, 200 mg daily, substantially reduced menstrual blood loss and provided a 'carry over' effect for 2 to 3 months (Chimbira et al., 1979. 1980).

In the present study we sought to confirm and extend previous findings, and compared danazol with placebo under double blind conditions in patients with primary menorrhagia defined by symptoms. The follow up period was extended to 6 months in order to ascertain the duration of any post-treatment benefit.