ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial☆

Received 25 November 2008; received in revised form 22 May 2009; accepted 22 May 2009. published online 07 August 2009.

Abstract

Background

This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen.

Study Design

Three hundred twenty-three healthy women were randomized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year (13 pill packs). Pearl index, adverse event (AE) incidence and bleeding profiles were assessed.

Results

No pregnancies occurred with the continuous oral contraceptive (OC) (Pearl index=0.00). As the study progressed, the percentage of women who achieved amenorrhea during each 28-day pill pack increased: 40% at pill pack 7, 53% at pill pack 13. The percentage of women with no bleeding [with or without spotting (defined as not requiring sanitary protection)] was 50%, 69% and 79% at pill packs 3, 7 and 13, respectively. The incidence of AEs was similar to that of the cyclic OC (except for metrorrhagia and vaginal bleeding in the first 6 months).

Conclusions

Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.

Keywords: Continuous oral contraceptive, Efficacy, Levonorgestrel, Menses suppression, Safety

a Frauenklinik, Klinikum Aschaffenburg, 63739 Aschaffenburg, Germany

b Väestöliitto/The Sexual Health Clinic, FIN-00100 Helsinki, Finland

c Institute of Obstetric and Gynecology, Medical University of Gdańsk, 80-402 Gdańsk, Poland

d 30459 Hannover, Germany

e Department of Obstetrics and Gynecology, University of Cagliari, 09124 Cagliari, Italy

f Department of Gynaecology, Obstetrics, and Gynaecologic Oncology, Division of Gynaecological Oncology, Poznan University of Medical Sciences, 61-535 Poznan, Poland

g Research Headquarters, Wyeth Pharmaceuticals, Collegeville, PA 19426, USA

h Women's Health, Wyeth Research, 92931 Paris, France

Corresponding author. Tel.: +1 610 353 3599.

☆ This study was sponsored by Wyeth Research, Collegeville, PA.

† Deceased.

PII: S0010-7824(09)00297-2

doi:10.1016/j.contraception.2009.05.128

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