Evaluation of the efficacy, tolerability and cycle control of a monophasic oral contraceptive containing gestodene and ethinylestradiol (Minulet^®) in women over 35 years of age

Abstract

The efficacy, tolerability and cycle control of a monophasic oral contraceptive preparation containing gestodene (75μg) plus ethinylestradiol (30 μg) (Minulet^®) were studied in 139 women aged over 35 years (mean age 37.12 ± 2.47 years) in a prospective, open-label, non-comparative study. Each subject received one tablet daily for 21 days followed by 7 days without medication, for six cycles. Of the 809 cycles studied, 96.04% had normal withdrawal bleeding, without breakthrough bleeding or spotting. The mean menstrual cycle length and duration of withdrawal bleeding were similar before and after treatment. The percentage of severe withdrawal bleeding cycles was reduced and the percentage of mild withdrawal bleeding cycles increased following treatment. No incidence of amenorrhea was observed and no pregnancies were reported. Five subjects withdrew due to adverse events. The most frequent symptoms reported during the study were breast tenderness, headache, nausea, nervousness and depression. Minulet, a low-dose combined, monophasic oral contraceptive formulation was shown to provide effective contraceptive protection, good cycle control and tolerability in women over the age of 35 years.

Key Words:

• Oral Contraceptives
• Gestodene
• Ethinylestradiol
• Older Women