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


METHODS
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/m(2) 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.


CONCLUSIONS
Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women.
Hernádi
László
L
Department of Obstetrics and Gynaecology, Markhot F. Heves County Hospital, Eger, Hungary.
Marr
Joachim
J
Trummer
Dietmar
D
De Leo
Vincenzo
V
Petraglia
Felice
F
D000328:Adult; D000736:Androstenes / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D005260:Female; D006801:Humans; D055118:Medication Adherence; D017060:Patient Satisfaction; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D016387:Women's Health; D055815:Young Adult
D000736:Androstenes; D003692:Delayed-Action Preparations; D004967:Estrogens; D045167:Progesterone Congeners; D004997:Ethinyl Estradiol; C035144:drospirenone