Clinical trial with subdermal implants of the progestin R-2323

Six 3-cm polydimethylsiloxane capsules containing 30 mg each of R-2323 were implanted subdermally in each of 38 women to assess their effect upon fertility, menstrual pattern, some aspects of metabolism and the incidence of side effects associated with the use of this hormonal contraceptive. There were no pregnancies in a total of 292 months of exposure. The longest duration of use was 12 months and the median was between 8 and 9 months. Amenorrhea and signs of androgenicity such as acne and hyperthricosis were common complaints and a frequent reason for closure. Headache and nervousness also were reported by a high proportion of patients. Blood and urine analyses were normal with the exception of elevated transaminases in 20 out of 27 patients after the third month of treatment. Side effects and elevation of the serum transaminase levels disappeared promptly after removal of the implants in all cases. It is concluded that R-2323 implants at the dose tested are potent inhibitors of fertility in women. The high incidence of treatment-associated adverse reactions impose limitations on their use in Chilean women.