A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene-and monophasic desogestrel-containing oral contraceptives

Abstract

This was an open-label, multicenter study to compare the cycle control and effect on well-being of two gestodene-containing and one desogestrel-containing oral contraceptive. Healthy women aged < 45 years were randomized to receiue oral contraceptives containing monophasic gestodene (n = 3 74; mean age 24.7 years), triphasic gestodene (n = 362; mean age 25.1 years) or desogestrel (n = 361; mean age 25.2 years). This paper describes preliminary data from subjects who had completed up to nine treatment cycles. A modified Moos Menstrual Distress Questionnaire was used to measure menstrual distress and to calculate overall well-being.

A total of 94 women were withdrawn from the study, 62 due to adverse events. Cycle control with gestodene was superior to that with desogestrel at almost all time-points, particularly for breakthrough bleeding and/or spotting, which occurred significantly less often with gestodene at cycles 1-3 than with desogestrel (p < 0.05). The mean duration of bleeding was slightly shorter with gestodene compared with desogestrel (by 0.25 days), but the intensity of bleeding was higher (p < 0.05). Treatment did not significantly affect overall well-being, but behavioral change and negative effect were improved to a significantly greater extent by gestodene than by desogestrel (p < 0.05). Tolerance of the three treatments was excellent; the most common drug-related adverse events were headache (11.5%), breast pain (4.6%), nausea (3.5%), abdominal pain (2.7%) and metrorrhagia (2.5%).

Key Words:

• Monofhasic Gestodene
• Triphasic Gestodene
• Desogestrel
• Oral Contraceptives
• Cycle Control
• Well-being