Efficacy and safety of Org OD 14 in the treatment of climacteric complaints.

To study the effect of Org OD 14 [17 alpha, 17 alpha)-17-hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one) on the endometrium, 9 healthy post-menopausal women were given a daily dose of 2.5 mg of Org OD 14 for 100 consecutive days. In addition, during days 91-100 a daily oral dose of 1 mg of lynestrenol was taken by each volunteer. Endometrial biopsies were obtained before the start of treatment and on day 91. At pre-treatment, the endometrium was atrophic in 7 out of 9 volunteers and weakly stimulated in 2 volunteers. On day 91, the endometrium was found atrophic in 8 out of 9 volunteers and weakly stimulated in 1. Breakthrough bleeding occurred in 1 volunteer. After cessation of the combined treatment with Org OD 14 and lynestrenol, withdrawal bleeding occurred only in 1 volunteer. To assess the efficacy of Org OD 14 in the treatment of climacteric complaints a double-blind cross-over study was performed in 29 post-menopausal women. Patients were randomly allocated to Org OD 14 or to placebo as first treatment. Each period of treatment lasted 4 mth; no wash-out period was introduced. Patients took 1 Org OD 14 tablet (2.5 mg) or 1 placebo tablet per day. The patients scored hot flushes and sweating. At the end of the second treatment period, each patient was asked which of the 2 treatments she preferred. Data sufficient to allow for a conclusion were obtained from 20 patients.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes