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A multicenter study of levonorgestrel—Estradiol contraceptive vaginal rings II — Subjective and objective measures of effects

An international comparative trial
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      Abstract

      Comparative clinical trials of 2 sizes of contraceptive vaginal rings and of an oral contraceptive were undertaken at 8 investigational sites (9 clinics). More than 500 women enrolled on each of the 3 study regimens. Side effects of the rings and of Nordette,
      Nordette is a registered trademark of Wyeth-Pharma, Munster, West Germany.
      Nordette is a registered trademark of Wyeth-Pharma, Munster, West Germany.
      the oral contraceptive, were evaluated by noting spontaneous complaints, by recording medications taken and by physical examination. Inquiries about changes in the frequency of specific conditions were made at the end of the subjects' participation in the first year of the study. The incidence of spontaneous complaints was similar among users of the 2 different-sized rings and of the pill. Vaginal and menstrual complaints were significantly more frequent among ring users. Headaches, dizziness and nausea were reported significantly more frequently by users of Nordette. All the regimens were associated with weight gain and increased hemoglobin levels. Nordette was associated with small but significant increases in both diastolic and systolic blood pressure.
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