Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen

Abstract Objective The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen). Study Design In th...

Full description

Saved in:
Bibliographic Details
Published in:Contraception (Stoneham) 2009-07, Vol.80 (1), p.18-24
Main Authors: Hernádi, László, Marr, Joachim, Trummer, Dietmar, De Leo, Vincenzo, Petraglia, Felice
Format: Article
Language:English
Subjects:
Adult
Androstenes - administration & dosage
Androstenes - adverse effects
Biological and medical sciences
Birth control
Combined oral contraceptives
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - adverse effects
Drospirenone
Estrogens - administration & dosage
Estrogens - adverse effects
Ethinyl Estradiol - administration & dosage
Ethinyl Estradiol - adverse effects
Ethinylestradiol
Europe
Female
Genital system. Reproduction
Gynecology. Andrology. Obstetrics
Hormonal contraception
Humans
Medical sciences
Medication Adherence
Obstetrics and Gynecology
Patient Satisfaction
Pearl Index
Pharmacology. Drug treatments
Progesterone Congeners - administration & dosage
Progesterone Congeners - adverse effects
Women's Health
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Objective The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen). Study Design In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18–35 years with a body mass index of less than 30 kg/m2 received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies. Results Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for ‘perfect use’ of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles. Conclusion Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women.
ISSN:0010-7824
1879-0518
DOI:10.1016/j.contraception.2009.01.016