Norgestrel and Ethynyl Estradiol: A New Low-Dosage Oral Agent for Fertility Control

To study the safety and efficacy of a norgestrel-ethinyl estradol oral contraceptive compound 300 Mexican women 16-42 years of age were orally administered .5 mg norgestrel and .05 mg ethinyl estradiol (Ovral) daily over a total of 3175 study cycles. Most of the women were poor. uneducated and of high parity. None of the patients in the study became pregnant even in the cycles where 1 or more doses were omitted. The menstrual cycle remained basically unaltered with breakthrough bleeding or spotting sometimes reported usually when doses were missed. Unexplained amenorrhea occurred in 1.2% of the cycles. Though 5% of the women were ovulatory at one time of another as determined by pregnandiol levels no pregnancy resulted which is probably explained by changes in the cervical mucus caused by the pills making an inhospitable environment for sperm migration. Psychosomatic-related side-effects included nausea headache and decreased libido in less than 1% of the cycles. Chloasma aggravated by poor dietary intake occurred in .5% of the cycles. No malignant peripheral vascular or other serious disease occurred during the treatment and no significant endometrial alterations were seen.