PMID- 21757054
OWN - NLM
STAT- MEDLINE
DCOM- 20111108
LR  - 20141120
IS  - 1879-0518 (Electronic)
IS  - 0010-7824 (Linking)
VI  - 84
IP  - 2
DP  - 2011 Aug
TI  - Effect of extended-cycle regimen with an oral contraceptive containing 30 mcg 
      ethinylestradiol and 2 mg dienogest on bleeding patterns, safety, acceptance and 
      contraceptive efficacy.
PG  - 133-43
LID - 10.1016/j.contraception.2011.01.002 [doi]
AB  - BACKGROUND: The present study compared the efficacy and safety of a combined oral 
      contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest (EE/DNG) in 
      conventional and extended-cycle regimen over 1 year of treatment. STUDY DESIGN: 
      In a phase III, randomized, prospective, open, two-arm, multicenter study, 1315 
      sexually active women (range, 18-40 years) were treated with EE/DNG either 
      conventionally (21/7 days) or according to an extended-cycle regimen (84/7 days). 
      Data were documented on volunteer diaries, and adverse events (AEs) were reported 
      during five visits. RESULTS: In the extended-regimen group, the total number of 
      days with bleeding progressively decreased over time, and overall, the volunteers 
      had fewer numbers of days with bleeding/spotting compared to those treated 
      conventionally. Intracyclic bleeding, on the other hand, was more frequent in the 
      extended-cycle group, although its frequency considerably decreased over time. 
      Both regimens offered reliable contraception, with an unadjusted Pearl Index of 
      0.489 for the conventional regimen and 0.495 for the extended regimen. The number 
      of AEs was higher in the extended-cycle group, although the group differences 
      tended to decrease over time. CONCLUSIONS: Extended-cycle use of EE/DNG was 
      effective and mostly well tolerated, appearing to be a favorable option for women 
      who need or wish to omit the pill-free interval.
CI  - Copyright (c) 2011 Elsevier Inc. All rights reserved.
FAU - Wiegratz, Inka
AU  - Wiegratz I
AD  - Center of Obstetrics and Gynecology, University Hospital of Frankfurt, Germany. 
      Inka.Wiegratz@kgu.de
FAU - Stahlberg, Skadi
AU  - Stahlberg S
FAU - Manthey, Torsten
AU  - Manthey T
FAU - Sanger, Nicole
AU  - Sanger N
FAU - Mittmann, Katrin
AU  - Mittmann K
FAU - Lange, Evelyn
AU  - Lange E
FAU - Mellinger, Uwe
AU  - Mellinger U
FAU - Palombo-Kinne, Ernesta
AU  - Palombo-Kinne E
FAU - Kuhl, Herbert
AU  - Kuhl H
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110221
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Contraceptives, Oral)
RN  - 0 (Estrogens)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 46M3EV8HHE (dienogest)
RN  - 6PG9VR430D (Nandrolone)
SB  - IM
MH  - Adult
MH  - Contraceptives, Oral/*administration & dosage
MH  - Estrogens/*administration & dosage/adverse effects
MH  - Ethinyl Estradiol/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Menstruation/*drug effects
MH  - Nandrolone/administration & dosage/*analogs & derivatives
MH  - Patient Satisfaction/statistics & numerical data
MH  - Prospective Studies
MH  - Young Adult
EDAT- 2011/07/16 06:00
MHDA- 2011/11/09 06:00
CRDT- 2011/07/16 06:00
PHST- 2010/07/26 00:00 [received]
PHST- 2010/12/28 00:00 [revised]
PHST- 2011/01/06 00:00 [accepted]
PHST- 2011/07/16 06:00 [entrez]
PHST- 2011/07/16 06:00 [pubmed]
PHST- 2011/11/09 06:00 [medline]
AID - S0010-7824(11)00003-5 [pii]
AID - 10.1016/j.contraception.2011.01.002 [doi]
PST - ppublish
SO  - Contraception. 2011 Aug;84(2):133-43. doi: 10.1016/j.contraception.2011.01.002. 
      Epub 2011 Feb 21.