Intravaginal contraception with the synthetic progestin, R2010

Abstract

Four women used polysiloxane vaginal rings of core design containing 50 mg of norgestrienone (17 alpha-ethynyl-17 beta-hydroxy-estra-4,9,11,trien-3-one). The treatment was given in three-week cycles, leaving one treatment-free week between the cycles. The patterns of bleeding were registered and plasma norgestrienone (R2010), estradiol, progesterone, and gonadotropins were determined. Altogether twelve cycles were studied. The patterns of bleeding were unsatisfactory; only one subject had regular bleedings, and two of these were preceded by a luteal phase. The mean plasma concentration of norgestrienone (R2010) produced by the rings was 0.9 ng/ml. Ovulation was observed in 25% of cycles studied. Some follicular activity was present in every subject as judged by estradiol peaks. Excluding LH peaks in subjects who ovulated, mild pituitary suppression was achieved by this treatment. The only side-effect complained of was acne in one subject. The ring was regarded as easy to use.

PIP: The clinical performance as well as effects on gonadal and pituitary functions were analyzed during use of a contraceptive vaginal ring (CVR) impregnated with R2010, a synthetic progestin. 4 regularly menstruating women aged 25-29 years, who were parous and married, volunteered, and treatment was given in 3-week periods, leaving 1 treatment-free week. The CVR was a polysiloxane ring of core design and contain 50 mg of norgestrienone. Bleeding patterns were registered along with plasma R2010, progesterone, estradiol, and gonadotropins (luteinizing and follicle stimulating hormones). A total of 12 cycles were studied for this investigation. Bleeding patterns were unsatisfactory. Only 1 of 4 subjects had regular, simulated menstrual bleedings; 2 of these bleedings were preceded by a luteal phase (according to hormone assays). Mean plasma concentration of the progestin produced by the rings was .9 ng/ml. In 25% of the cycles ovulation was observed; in addition, some follicular activity was present in all 4 subjects, based on measurement of estradiol peaks. Mild pituitary suppression was achieved in the 3 subjects who did not ovulate. An acne flare-up constituted the only reported side effect.