Clinical assessment of the effectiveness, cycle control and side-effects of Minulet^®as an oral contraceptive

Abstract

One hundred and fifty women between 18 and 25 years of age, who requested an oral contraceptive for the first time, completed this prospective, open-label, non-comparative 12-cycle study. Data for 148 women were analyzed to assess the contraceptive efficacy, acceptance, and tolerance of Minulet^®, a low-dose, combined monophasic oral contraceptive containing ethinylestradiol 30 μg and gestodene 75 μg. All women who met the study criteria, and gave written consent, were supplied with 21-day packs of Minulet on a monthly basis for 12 cycles. Assessments were made at baseline and after cycles 1, 3, 6 and 12. For safety evaluation, all adverse events were recorded. Data were analyzed using Student's t-testfor matched groups to compare initial conditions with those at subsequent visits. Variations were analyzed as frequency distributions and comparisons were made by applying the χ² test. There were no pregnancies during the study. After 12 cycles of Minulet use, there was a significant reduction in the duration and amount of menstrual flow, spotting, and duration of cycles (p < 0.01). There was also a significant reduction in different physical and emotional premenstrual syndrome symptoms, including breast engorgement, abdominal discomfort, edema, dizziness, anxiety, headache, depression, sensitivity and irritability (p < 0.001). There were no adverse reactions reported with Minulet after 12 cycles. There was no significant variation in weight. After 12 cycles, there was a nonsignificant trend to lower mean arterial blood pressure (85.49 mmHg vs. 84.70 mmHg). Minulet appears to be a safe and effective oral contraceptive that may also offer a significant reduction in the symptoms of premenstrual syndrome.

Key Words:

• Cycle Control
• Side-Effects
• Oral Contraceptive
• Efficacy
• Ethinylestradiol
• Gestodene