Abstract

To evaluate the effect of oral contraception formulation with drospirenone (Yasmin) on premenstrual symptoms. An open-label non-comparative clinical trial was conducted. One hundred women who desired oral contraception for at least 6 months were recruited. The subjects received a blister pack which contained 21 tablets of 3 mg drospirenone/30 microg ethinyl estradiol for the first four cycles (1 cycle = 28 days). Cycle-5 and -6 blister packs were dispensed during the next visit in cycle 4. The subjects were evaluated on menstruation-related symptoms by using the women's health assessment questionnaire (WHAQ) at baseline and at each follow-up visit for three phases of their menstrual cycle. The measured outcome was the mean score changes from baseline to cycle 6 of WHAQ categories. Of the total 100 subjects, 92 (92%) completed the study. At the premenstrual phase, a significant decrease was seen from baseline to cycle 6 in the mean WHAQ scores for impaired concentration, water retention, negative effect, increased appetite, feeling of well-being and undesirable hair change. At the menstrual phase, a significant decrease was seen from baseline to cycle 6 regarding the mean WHAQ scores for impaired concentration, negative effect, feeling of well-being, and undesirable hair change. At the postmenstrual phase, significant changes were consistently observed regarding the feeling of well-being and undesirable hair change. Oral contraception formulation with drospirenone (Yasmin) has an ameliorating effect on premenstrual symptoms. This oral contraception may have a role in women who are looking forward to use contraception and also suffer from premenstrual symptoms.

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