EVALUATION OF AN ESTROGEN, ANDROGEN, ESTROGEN-ANDROGEN COMBINATION, AND A PLACEBO IN THE TREATMENT OF THE MENOPAUSE*

Abstract
284 courses of therapy with 4 prepns. were administered in varying sequence to 102 patients with symptoms of the menopause. These prepns., labeled "AE-1", "AE-2", "AE-3" and "AE-4", contained diethylstilbestrol (0.25 mg.), a combination of methyl testosterone (5.0 mg.) and diethylstilbestrol (0.25 mg.), methyltestosterone (5.0 mg.) alone, and a placebo, respectively. The specific content of each prepn. was not known for this study, so that suggestion and pre-existing preferance were circumvented in evaluation of these prepns. Although both AE-1 and AE-2 gave equally good results in amelioration of symptoms, AE-2 was preferred by most patients because of greater increase in libido and well being as well as decreased amt. and frequency of uterine bleeding. Although only 50% of the patients receiving AE-3 as initial therapy derived satisfactory relief of symptoms there was in general a tendency for methyl-testosterone to perpetuate the estrogenic smear and satisfactory results of previous estrogen treatment. Mild acne was occasionally noted during therapy with AE-2 and AE-3. Response to treatment with AE-4 was in general disappointing, as symptoms were relieved in only 7.1 % of patients. From an analysis of this clinical study we were able to meet satisfactorily the challenge of determining the content of each of the AE prepns. Estrogen and androgen therapy, individually or in combination, gave the best results. The placebo, in the true menopausal patient, proved inadequate.