A COMPARATIVE-STUDY OF DANAZOL, A REGIMEN OF DECREASING DOSES OF DANAZOL, AND NORETHINDRONE IN THE TREATMENT OF OBJECTIVELY PROVEN UNEXPLAINED MENORRHAGIA

OBJECTIVE: Our purpose was to compare the efficacy of the recommended dose of danazol, a reduced-dose danazol regimen, and norethindrone in the treatment of objectively proven menorrhagia. Recurrence after disc ontinuing treatment was also assessed. STUDY DESIGN: The study was a s ingle-blind, randomized, parallel, comparative study. After a placebo run-in period over two menstrual cycles, 57 patients with a baseline m ean menstrual blood loss of at least 80 ml per cycle were randomly ass igned to receive one of three therapies: danazol, 200 mg/day (n = 19) for three menstrual cycles; danazol, 200 mg/day for one cycle, 100 mg/ day for one cycle, and 50 mg/day for one cycle (n = 19); and norethind rone, 5 mg three times daily on days 19 through 26 of the cycle for th ree consecutive cycles (n = 19). Patients in whom treatment was succes sful (those experiencing blood loss < 80 ml) were entered in the follo w-up phase of the study, receiving placebo for a maximum of four menst rual cycles. RESULTS: The final menstrual blood loss on treatment was significantly less for those patients who received both danazol regime ns compared with those who received norethindrone (p = 0.017 for reduc ing dose danazol vs norethindrone and p = 0.043 for 200 mg of danazol vs norethindrone). Both danazol treatment regimens were significantly more successful in reducing menstrual blood loss to within the normal range than was norethindrone. The reducing-dose danazol regimen was su ccessful in eight of 17 patients (p = 0.027), and 200 mg of danazol wa s successful in nine of 19 patients (p = 0.029), compared with the two successes of 18 patients treated with norethindrone. Significantly mo re recipients of 200 mg of danazol than of norethindrone subjectively rated their treatment to be moderately or highly effective (p = 0.033) . Both danazol treatment regimens were associated with a higher incide nce of adverse events than was norethindrone therapy, although the num ber of withdrawals were similar and infrequent in the three groups. CO NCLUSIONS: Both danazol regimens were significantly more effective tha n norethindrone in reducing the excessive menstrual blood loss of wome n with unexplained menorrhagia. A subjective assessemnt by patients fo und that only the 200 mg of danazol was judged to be significantly mor e effective than norethindrone in controlling the heaviness of menstru al bleeding. The reduced-dose danazol regimen did not appear to marked ly diminish the incidence of adverse events compared with the 200 mg o f danazol regimen.