An open-label study of the effects of a 24-day regimen of gestodene 60 µg/ethinylestradiol 15 µg on endometrial histological findings in healthy women

Abstract

Objectives: This open-label, non-comparative study was conducted at a single center to evaluate the effects on the endometrium of a 24-day regimen of a combined oral contraceptive containing gestodene (GTD) 60 µg and ethinylestradiol (EE) 15 µg.

Methods: Healthy parous women who were ≥ 18 years old and had had regular menstrual cycles for the prior 3 months were randomly assigned to one of two groups. Subjects in group A underwent endometrial biopsies during the late luteal phase of the pretreatment cycle and between days 15 and 24 of cycle 6. Subjects in group B had biopsies between days 15 and 24 of cycle 3 and during the late luteal phase of the post-treatment cycle. GTD 60 µg/EE 15 µg was taken for the first 24 days of a 28-day cycle, followed by placebo pills for 4 days, for a total of six cycles.

Results: Data from 27 women were included in the analyses. Eleven of the 13 evaluable baseline biopsies were classified as secretory. Three of nine subjects with evaluable biopsies at cycle 3 and four of nine subjects with evaluable biopsies at cycle 6 had an atrophic endometrium. Post-treatment biopsies showed a typical secretory endometrium in seven of 11 subjects with evaluable biopsies.

Conclusions: The results of this study show that the 24-day regimen of GTD 60 µg/EE 15 µg produced effective endometrial suppression.

Key Words:

• Oral contraceptives
• Endometrial suppression
• Gestodene
• Ethinylestraiol