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An open-label study of the effects of a 24-day regimen of gestodene 60 microg/ethinylestradiol 15 microg on endometrial histological findings in healthy women.
Eur J Contracept Reprod Health Care. 1999 Nov; 4 Suppl 2:3-8.EJ

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 microg and ethinylestradiol (EE) 15 microg.

METHODS

Healthy parous women who were > or = 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 microg/EE 15 microg 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 microg/EE 15 microg produced effective endometrial suppression.

Authors+Show Affiliations

Bosch Medicentrum, Groot Ziekengasthuis, Den Bosch, The Netherlands.

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

14677619

Citation

Oosterbaan, H P.. "An Open-label Study of the Effects of a 24-day Regimen of Gestodene 60 Microg/ethinylestradiol 15 Microg On Endometrial Histological Findings in Healthy Women." The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, vol. 4 Suppl 2, 1999, pp. 3-8.
Oosterbaan HP. An open-label study of the effects of a 24-day regimen of gestodene 60 microg/ethinylestradiol 15 microg on endometrial histological findings in healthy women. Eur J Contracept Reprod Health Care. 1999;4 Suppl 2:3-8.
Oosterbaan, H. P. (1999). An open-label study of the effects of a 24-day regimen of gestodene 60 microg/ethinylestradiol 15 microg on endometrial histological findings in healthy women. The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, 4 Suppl 2, 3-8.
Oosterbaan HP. An Open-label Study of the Effects of a 24-day Regimen of Gestodene 60 Microg/ethinylestradiol 15 Microg On Endometrial Histological Findings in Healthy Women. Eur J Contracept Reprod Health Care. 1999;4 Suppl 2:3-8. PubMed PMID: 14677619.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label study of the effects of a 24-day regimen of gestodene 60 microg/ethinylestradiol 15 microg on endometrial histological findings in healthy women. A1 - Oosterbaan,H P, PY - 2003/12/18/pubmed PY - 2004/1/22/medline PY - 2003/12/18/entrez SP - 3 EP - 8 JF - The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception JO - Eur J Contracept Reprod Health Care VL - 4 Suppl 2 N2 - 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 microg and ethinylestradiol (EE) 15 microg. METHODS: Healthy parous women who were > or = 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 microg/EE 15 microg 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 microg/EE 15 microg produced effective endometrial suppression. SN - 1362-5187 UR - https://www.unboundmedicine.com/medline/citation/14677619/An_open_label_study_of_the_effects_of_a_24_day_regimen_of_gestodene_60_microg/ethinylestradiol_15_microg_on_endometrial_histological_findings_in_healthy_women_ L2 - http://www.tandfonline.com/doi/full/10.3109/13625189909085264 DB - PRIME DP - Unbound Medicine ER -