PMID- 26499407
OWN - NLM
STAT- MEDLINE
DCOM- 20161114
LR  - 20161230
IS  - 1879-0518 (Electronic)
IS  - 0010-7824 (Linking)
VI  - 93
IP  - 3
DP  - 2016 Mar
TI  - Efficacy and safety of a 21/7-active combined oral contraceptive with continuous 
      low-dose ethinyl estradiol.
PG  - 249-56
LID - S0010-7824(15)00623-X [pii]
LID - 10.1016/j.contraception.2015.10.007 [doi]
AB  - OBJECTIVE: Substituting low-dose ethinyl estradiol (EE) for the hormone-free 
      interval in combined oral contraceptives (COCs) may enhance ovarian suppression 
      and improve tolerability. This noncomparative phase 3 study evaluated the 
      efficacy and safety of a 21/7-active COC regimen including 21days of desogestrel 
      (DSG)/EE followed by 7days of EE. STUDY DESIGN: This multicenter, open-label, 
      phase 3, single-arm study enrolled sexually active women aged 18-40years at risk 
      for pregnancy. Women received up to 1year, or 13 consecutive 28-day cycles, of 
      DSG 150mcg/EE 20mcg for 21days and EE 10mcg alone for 7days. Participants kept 
      diaries to record compliance, bleeding/spotting and other contraceptive use. 
      Efficacy was measured using the Pearl Index (PI) and life-table approach. Safety 
      and tolerability were assessed primarily through reported adverse events (AEs). 
      RESULTS: A total of 2858 women enrolled and 1680 completed the study. Forty-six 
      pregnancies in 2401 women aged 18-35years occurred after COC initiation and up to 
      7days after last DSG/EE or EE-only tablet was taken. When cycles in which another 
      contraceptive method was used were excluded, the PI was 2.68 [95% confidence 
      interval (CI), 1.96-3.57]. The cumulative pregnancy rate after 1year of treatment 
      was 2.47% (95% CI, 1.85-3.29) for all users aged 18-35years. When only cycles 
      during which women considered compliant were included, the PI was 2.00 (95% CI, 
      1.39-2.80). AEs were similar to those seen with other oral contraceptives. 
      CONCLUSIONS: This 21/7-active DSG/EE COC with 7days of low-dose EE was 
      efficacious and well tolerated for pregnancy prevention. IMPLICATIONS STATEMENT: 
      This phase 3 open-label study demonstrated that a 21/7-active COC regimen 
      including 21days of DSG 150mcg/EE 20mcg and 7days of EE 10mcg was efficacious and 
      well tolerated for pregnancy prevention.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Kroll, Robin
AU  - Kroll R
AD  - Women's Clinical Research Center, 3216 NE 45th Place, Suite 100, Seattle, WA 
      98105, USA. Electronic address: rkroll@seattlewomens.com.
FAU - Ackerman, Ronald
AU  - Ackerman R
AD  - Comprehensive Clinical Trials LLC, 603 Village Blvd., Suite 301, West Palm Beach, 
      FL 33409, USA. Electronic address: gobs@earthlink.net.
FAU - Feldman, Robert
AU  - Feldman R
AD  - Miami Research Associates, 6141 Sunset Drive, Miami, FL 33143, USA. Electronic 
      address: rfeldman@miamiresearch.com.
FAU - Howard, Brandon
AU  - Howard B
AD  - Teva Global Medical Affairs, 41 Moores Road, Frazer, PA 19355, USA. Electronic 
      address: Brandon.Howard@tevapharm.com.
FAU - Weiss, Herman
AU  - Weiss H
AD  - Teva Global Medical Affairs, 16 Basel St., Room 1041, Petach Tikva 49131, Israel. 
      Electronic address: Herman.Weiss@teva.co.il.
FAU - Hsieh, Jennifer
AU  - Hsieh J
AD  - Teva Branded Pharmaceutical Products R&D Inc., 905 Airport Road, West Chester, PA 
      19380, USA. Electronic address: Jennifer.Hsieh@tevapharm.com.
FAU - Ricciotti, Nancy
AU  - Ricciotti N
AD  - Teva Branded Pharmaceutical Products R&D Inc., 41 Moores Road, Frazer, PA 19355, 
      USA. Electronic address: nancyricciotti@gmail.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20151020
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 81K9V7M3A3 (Desogestrel)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Contraceptives, Oral, Combined/*administration & dosage/*adverse effects
MH  - Desogestrel/administration & dosage/adverse effects
MH  - Ethinyl Estradiol/*administration & dosage/*adverse effects
MH  - Female
MH  - Humans
MH  - Menstrual Cycle
MH  - Pregnancy
MH  - Pregnancy Rate
MH  - Young Adult
OTO - NOTNLM
OT  - Birth control pill
OT  - Contraception
OT  - Hormone-free interval
OT  - Phase 3 trial
EDAT- 2015/10/27 06:00
MHDA- 2016/11/15 06:00
CRDT- 2015/10/27 06:00
PHST- 2015/04/13 00:00 [received]
PHST- 2015/10/14 00:00 [revised]
PHST- 2015/10/15 00:00 [accepted]
PHST- 2015/10/27 06:00 [entrez]
PHST- 2015/10/27 06:00 [pubmed]
PHST- 2016/11/15 06:00 [medline]
AID - S0010-7824(15)00623-X [pii]
AID - 10.1016/j.contraception.2015.10.007 [doi]
PST - ppublish
SO  - Contraception. 2016 Mar;93(3):249-56. doi: 10.1016/j.contraception.2015.10.007. 
      Epub 2015 Oct 20.