PMID- 19501211
OWN - NLM
STAT- MEDLINE
DCOM- 20090915
LR  - 20220316
IS  - 1879-0518 (Electronic)
IS  - 0010-7824 (Linking)
VI  - 80
IP  - 1
DP  - 2009 Jul
TI  - Efficacy and safety of a low-dose combined oral contraceptive containing 
      drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen.
PG  - 18-24
LID - 10.1016/j.contraception.2009.01.016 [doi]
AB  - 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/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. CONCLUSION: 
      Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women.
FAU - Hernadi, Laszlo
AU  - Hernadi L
AD  - Department of Obstetrics and Gynaecology, Markhot F. Heves County Hospital, Eger, 
      Hungary.
FAU - Marr, Joachim
AU  - Marr J
FAU - Trummer, Dietmar
AU  - Trummer D
FAU - De Leo, Vincenzo
AU  - De Leo V
FAU - Petraglia, Felice
AU  - Petraglia F
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20090318
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Androstenes)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Estrogens)
RN  - 0 (Progesterone Congeners)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - N295J34A25 (drospirenone)
SB  - IM
MH  - Adult
MH  - Androstenes/*administration & dosage/adverse effects
MH  - Delayed-Action Preparations/administration & dosage/adverse effects
MH  - Estrogens/*administration & dosage/adverse effects
MH  - Ethinyl Estradiol/*administration & dosage/adverse effects
MH  - Europe
MH  - Female
MH  - Humans
MH  - Medication Adherence
MH  - Patient Satisfaction
MH  - Progesterone Congeners/*administration & dosage/adverse effects
MH  - Women's Health
MH  - Young Adult
EDAT- 2009/06/09 09:00
MHDA- 2009/09/16 06:00
CRDT- 2009/06/09 09:00
PHST- 2008/05/27 00:00 [received]
PHST- 2009/01/23 00:00 [revised]
PHST- 2009/01/28 00:00 [accepted]
PHST- 2009/06/09 09:00 [entrez]
PHST- 2009/06/09 09:00 [pubmed]
PHST- 2009/09/16 06:00 [medline]
AID - S0010-7824(09)00037-7 [pii]
AID - 10.1016/j.contraception.2009.01.016 [doi]
PST - ppublish
SO  - Contraception. 2009 Jul;80(1):18-24. doi: 10.1016/j.contraception.2009.01.016. 
      Epub 2009 Mar 18.