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Complexion changes in oral contraceptive users. Results from a phase IV multicenter trial evaluating the safety and efficacy of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms.

Author(s): Wheeler JM, Malinak LR

Affiliation(s): Department of Obstetrics and Gynecology, Methodist Hospital, Houston, Texas 77030.

Publication date & source: 1991-04, J Reprod Med., 36(4 Suppl):340-4.

Publication type: Clinical Trial; Multicenter Study

An open-label, phase IV, multicenter survey of obstetrician-gynecologists was conducted to evaluate the efficacy and safety of a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms. Surveys from 983 community-based physicians reported on 6,382 women. Most patients did not experience "clinically noticeable complexion changes" (5,695/6,382, or 89.2%). Of the 687 patients with complexion changes, nearly three-fourths reported an improvement (501/687, or 72.9%). A follow-up questionnaire was sent to 127 respondents (18.6%) who reported worsening of the complexion; 70% of the questionnaires were returned. Most complexion worsening was of slight degree (63%), reported by the patient and not the physician (84% vs. 16%), and experienced during the first two to three months (84%). Although the literature includes many references to skin condition "improvement" on oral contraceptives, this report of a descriptive study gives clinicians as estimate of the incidence and severity of complexion changes in actual use.

Page last updated: 2007-10-18

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