PMID- 24576794
OWN - NLM
STAT- MEDLINE
DCOM- 20141121
LR  - 20140331
IS  - 1879-0518 (Electronic)
IS  - 0010-7824 (Linking)
VI  - 89
IP  - 4
DP  - 2014 Apr
TI  - Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl 
      estradiol combined oral contraceptive.
PG  - 299-306
LID - S0010-7824(14)00023-7 [pii]
LID - 10.1016/j.contraception.2014.01.013 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of an ascending-dose, 
      extended-regimen (ADER) combined oral contraceptive consisting of levonorgestrel 
      (LNG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 42 days, LNG 150 mcg/EE 25 mcg 
      for 21 days, LNG 150 mcg/EE 30 mcg for 21 days and EE 10 mcg for 7 days. STUDY 
      DESIGN: This was a multicenter, open-label, phase 3, single-arm study. Sexually 
      active women aged 18-40 years were enrolled and received ADER for up to 1 year (4 
      consecutive 91-day cycles). Participants kept diaries to record adherence, 
      bleeding/spotting and other contraceptive use. Efficacy was measured using the 
      Pearl Index and the life-table method; safety and tolerability were assessed 
      through reported adverse events (AEs). RESULTS: A total of 3701 women were 
      enrolled and 2144 completed the study. The Pearl Index was 3.19 [95% confidence 
      interval (CI), 2.49-4.03], based on 70 pregnancies that occurred after ADER 
      initiation and </= 7 days after the last LNG/EE or EE-only pill in women aged 18-35 
      years, excluding cycles in which another contraceptive method was used. 
      Life-table pregnancy rate was 2.82% (95% CI, 2.23%-3.57%) for all users aged 
      18-35 years. Unscheduled bleeding/spotting decreased with increasing EE doses 
      within each cycle and decreased after cycle 1. No unexpected AEs or changes in 
      laboratory parameters were reported. CONCLUSION: This study demonstrated that 
      ADER effectively prevented pregnancy with a favorable safety and tolerability 
      profile.
CI  - Copyright (c) 2014 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Portman, David J
AU  - Portman DJ
AD  - Columbus Center for Women's Health Research, Columbus, OH, USA. Electronic 
      address: dportman@ccwhr.com.
FAU - Kaunitz, Andrew M
AU  - Kaunitz AM
AD  - University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.
FAU - Howard, Brandon
AU  - Howard B
AD  - Teva Global Medical Affairs, Frazer, PA, USA.
FAU - Weiss, Herman
AU  - Weiss H
AD  - Teva Global Medical Affairs, Petach Tikva, Israel.
FAU - Hsieh, Jennifer
AU  - Hsieh J
AD  - Teva Branded Pharmaceutical Products, R&D, Inc., West Chester, PA, USA.
FAU - Ricciotti, Nancy
AU  - Ricciotti N
AD  - Teva Branded Pharmaceutical Products, R&D, Inc., Frazer, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00996580
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140129
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Estrogens)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Adult
MH  - Contraceptives, Oral, Combined/*adverse effects
MH  - Estrogens/*administration & dosage/adverse effects
MH  - Ethinyl Estradiol/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Levonorgestrel/*administration & dosage/adverse effects
MH  - Menstrual Cycle/drug effects
MH  - Pregnancy
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Bleeding
OT  - Contraception
OT  - Low dose
OT  - Spotting
EDAT- 2014/03/01 06:00
MHDA- 2014/12/15 06:00
CRDT- 2014/03/01 06:00
PHST- 2013/08/26 00:00 [received]
PHST- 2014/01/15 00:00 [revised]
PHST- 2014/01/18 00:00 [accepted]
PHST- 2014/03/01 06:00 [entrez]
PHST- 2014/03/01 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
AID - S0010-7824(14)00023-7 [pii]
AID - 10.1016/j.contraception.2014.01.013 [doi]
PST - ppublish
SO  - Contraception. 2014 Apr;89(4):299-306. doi: 10.1016/j.contraception.2014.01.013. 
      Epub 2014 Jan 29.