PMID- 22391750
OWN - NLM
STAT- MEDLINE
DCOM- 20120820
LR  - 20131121
IS  - 1872-7654 (Electronic)
IS  - 0301-2115 (Linking)
VI  - 162
IP  - 1
DP  - 2012 May
TI  - A historical cycle control comparison of two drospirenone-containing combined 
      oral contraceptives: ethinylestradiol 30 mug/drospirenone 3 mg administered in a 
      21/7 regimen versus ethinylestradiol 20 mug/drospirenone 3 mg administered in a 
      24/4 regimen.
PG  - 91-5
LID - 10.1016/j.ejogrb.2012.01.021 [doi]
AB  - OBJECTIVES: To compare the bleeding patterns and cycle control of an oral 
      contraceptive (OC) containing ethinylestradiol (EE) 30 mug/drospirenone (drsp) 3mg 
      administered in a 21/7 regimen versus a lower-dose OC containing EE 20 mug/drsp 
      3mg administered in a 24/4 regimen, using data from two identically designed 
      studies. MATERIALS AND METHODS: In the first study, 326 healthy women (18-35 
      years) received EE 30 mug/drsp 3mg in a 21/7 regimen. In the second study, 1027 
      healthy women (17-36 years) received EE 20 mug/drsp 3mg in a 24/4 regimen. 
      Participants recorded bleeding using daily completed diaries over 13 treatment 
      cycles. RESULTS: During cycles 1-12, the prevalence of scheduled withdrawal 
      bleeding was lower with EE 20 mug/drsp 3mg 24/4 than with EE 30 mug/drsp 3mg 21/7 
      (82.0-91.7% versus 94.8-100.0% of women, respectively); moreover, a higher 
      proportion of women reported a maximum intensity of light scheduled withdrawal 
      bleeding with EE 20 mug/drsp 3mg 24/4 than with EE 30 mug/drsp 3mg 21/7 (30.9-39.0% 
      versus 13.8-20.5% of women, respectively). In cycles 2-13, unscheduled 
      intracyclic bleeding was reported by 7.7-13.8% of EE 20 mug/drsp 3mg 24/4 
      recipients and 3.8-7.9% of EE 30 mug/drsp 3mg 21/7 recipients; these were mainly 
      single bleeding days. During reference periods 1-4, the mean number of bleeding 
      episodes was similar between groups (3.1-3.3 episodes with EE 20 mug/drsp 3mg 24/4 
      versus 3.2 episodes with EE 30 mug/drsp 3mg 21/7). CONCLUSIONS: A low-dose 24/4 
      regimen OC containing EE 20 mug/drsp 3mg is generally comparable in terms of 
      bleeding to a higher-dose 21/7 regimen OC containing EE30 mug/drsp 3mg. 
      Between-treatment differences in bleeding intensity and unscheduled intracyclic 
      bleeding rates were observed.
CI  - Copyright (c) 2012 Elsevier Ireland Ltd. All rights reserved.
FAU - Marr, Joachim
AU  - Marr J
AD  - Global Clinical Development, Women's Healthcare, Bayer HealthCare 
      Pharmaceuticals, Berlin, Germany. joachim.marr@bayer.com
FAU - Gerlinger, Christoph
AU  - Gerlinger C
FAU - Kunz, Michael
AU  - Kunz M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120304
PL  - Ireland
TA  - Eur J Obstet Gynecol Reprod Biol
JT  - European journal of obstetrics, gynecology, and reproductive biology
JID - 0375672
RN  - 0 (Androstenes)
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Contraceptives, Oral, Hormonal)
RN  - 0 (drospirenone and ethinyl estradiol combination)
RN  - 423D2T571U (Ethinyl Estradiol)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Androstenes/*administration & dosage/therapeutic use
MH  - Contraceptives, Oral, Combined/*administration & dosage/therapeutic use
MH  - Contraceptives, Oral, Hormonal/*administration & dosage/therapeutic use
MH  - Ethinyl Estradiol/*administration & dosage/therapeutic use
MH  - Female
MH  - Humans
MH  - Menstrual Cycle/*drug effects
MH  - Treatment Outcome
EDAT- 2012/03/07 06:00
MHDA- 2012/08/21 06:00
CRDT- 2012/03/07 06:00
PHST- 2011/03/01 00:00 [received]
PHST- 2012/01/03 00:00 [revised]
PHST- 2012/01/30 00:00 [accepted]
PHST- 2012/03/07 06:00 [entrez]
PHST- 2012/03/07 06:00 [pubmed]
PHST- 2012/08/21 06:00 [medline]
AID - S0301-2115(12)00064-4 [pii]
AID - 10.1016/j.ejogrb.2012.01.021 [doi]
PST - ppublish
SO  - Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):91-5. doi: 
      10.1016/j.ejogrb.2012.01.021. Epub 2012 Mar 4.