Clinical and Laboratory Evaluation of a New Progestational Compound

Abstract

A study was carried out to evaluate the systemic effects of a new and potent progestational compound ethynodiol diacetate. In combination with .1 mg mestranol 2 mg and 1 mg dose levels of this compound are known as Metrulen and Ovulen respectively. 18 patients took Metrulen and 12 received Ovulen for a total of 130 cycles. Various tests and assays were performed. It was determined that Metrulen and Ovulen are effective in conception control. 4 infertile patients became pregnant within 1-3 months after discontinuation of the medication indicating achievement of a rebound phenomenon which indirectly suggests an improvement of hormonal interaction and more receptive target organs (cervix vagina uterus and tubes). Side effects were transitory and did not necessitate discontinuation of therapy. There were no significant electrolyte changes. Vaginal cytologic changes and changes in cervical mucus and endometrium were all transient and there was a return to normal after completion of the treatment. Hormonal assays showed a definite decrease in all urinary hormones measured except gonadotropins in 4 cases. The metyrapone (SU 4885) test performed during progestin treatment reported for the first time yielded equivocal results.