Incidence of side effects with contraceptive placebo.

Aznar-Ramos R; Giner-Velazquez J; Lara-Ricalde R; Martinez-Manautou J
American Journal of Obstetrics and Gynecology. December 1, 1969; 105(7):1144-1149.

147 Mexican women, of low socioeconomic level, who had aborted spontaneously and desired pregnancy, were subjected to trial of placebo oral contraceptive. In 424 months there were 72 pregnancies, a Pearl index of 203.8 pregnancies per 100 couple-years. Menstrual cycles lasted 21-24 days in 30 women (9.8%), 25-35 days in 235 (76.8%), and 36-59 days in 38 (12.4%). 18 cycles (5.8%) were marked by intermenstrual bleeding. Incidence of 31 side effects is listed. Most common were: decreased libido 125 months (29.5%), headache 66 (15.6%), lower abdominal pain and bloating 58 (13.7%), dizziness 47 (11.1%). Common complaints were nervousness, increased libido, dysmenorrhea, nausea, epigastric pain, leg pain, leukorrhea, somnolence. Oral contraceptive-like side effects reported in fewer than 1% of months included acne, mastalgia, increased appetite, weight gain, painful varicose veins. Nausea (here 4.2% of months) was the only side effect with markedly different incidence from other studies with active oral contraceptives.

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