Pharmacodynamic Studies with a New Progestational Substance - Org 2969 - In Combination With Ethinyloestradiol

A new orally active progestin ORG 2969 (13-ethyl-ll-methylene-1819-dinor-17 alpha-pregn-4-en-20-yn-17-ol) was studied in combination with ethinyl estradiol (EE) to determine its ability to suppress ovulation and its effects on peripheral functions in human volunteers. .015 .03 .075 .1 and .125 mg of Org 2969 combined with .05 mg of EE; .05 mg of Org 2969 plus .03 mg of EE; or .15 mg of Org 2969 plus .02 mg of EE formulations were tested in 21-day cyclic regimens. In addition 2 normophasic regimens were tested. The 1st cycle in all dose groups served as control. Treatment cycles lasted up to 8 months. In 21 volunteers the 1st post-treatment cycle was also studied. During every cycle serum luteinizing hormone estradiol and follstimulating hormone were measured daily on Days 7-23 and serum progesterone on Days 14-23. Basal body temperature cervical mucus properties vaginal smears and endometrial biopsies were also observed routinely. Hormone determinations are presented in graphs; results suggested that all pretreatment cycles were ovulatory and all treatment cycles were anovulatory. In the majority of patients the 1st post-treatment cycle was ovulatory. Endometrial biopsies showed normal secretor pattern during pretreatment drug related changes during treatment and close to normal secretory pattern during post-treatment cycles. The other peripheral paramenters studied were also in accord with hormonal determinations.