Studies on the effect of 17alpha-ethinyl-6-estrene-5alpha, 7beta-diol on menstrual cycle and plasma and urinary hormones in normal women.

Pharmacological tests on rats and dogs showed that a novel steroid substance, ORG OI-65 (code name for 17alpha-ethinyl-6-estrene-5alpha, 7beta-diol) has both progestational and estrogenic properties. The effect of this substance on menstrual cycle was studied on 13 healthy fertile women, who received 2 mg of ORG OI-65 daily for 20 consecutive days from the 5th day of cycle. The following parameters were studied during pretreatment and treatment cycles: bleeding pattern, plasma progesterone, urinary excretion of FSH, LH and estrone, vaginal cytology, cervical mucus, endometrium biopsy and basal body temperature. Treatment with ORG OI-65 did not change the bleeding pattern or inhibit ovulation: all 12 cases with ovulatory pretreatment cycles showed evidence of ovulation--timely or delayed--also during ORG OI-65 treatment. The vaginal cytology and cervical mucus remained almost unaffected by the treatment. No serious side-effects were found. The authors conclude that ORG OI-65 2 mg daily is not effective enough for oral contraception.