PMID- 24279594
OWN - NLM
STAT- MEDLINE
DCOM- 20140512
LR  - 20220318
IS  - 1931-843X (Electronic)
IS  - 1540-9996 (Linking)
VI  - 23
IP  - 3
DP  - 2014 Mar
TI  - Efficacy and safety of a combined oral contraceptive containing estradiol 
      valerate/dienogest: results from a clinical study conducted in North America.
PG  - 204-10
LID - 10.1089/jwh.2013.4320 [doi]
AB  - BACKGROUND: This study investigated the efficacy and safety of a combined oral 
      contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). METHODS: 
      This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study 
      conducted in the United States and Canada. Contraceptive efficacy was calculated 
      as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; bleeding 
      patterns were calculated based on bleeding and spotting information recorded 
      daily in diary cards. Safety events during a 16-month extension study were added 
      to the 1-year data. RESULTS: In total, 499 women, aged 18-35 years, were 
      enrolled, and 490 of them were included in the full analysis set for 
      contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted 
      Pearl Index=1.64). In cycles 1-12, an average 23.5% of women had absent scheduled 
      (withdrawal) bleeding. Among women with scheduled (withdrawal) bleeding, bleeding 
      started after a median of 2 days after intake of the last DNG-containing pill. 
      For safety, data included from 147 women followed over an additional 16 months 
      were added to the original 13-cycle data set. Treatment-related adverse events 
      (AEs) occurred in 51.8% of women; 14.9% discontinued because of AEs over the 
      entire 28-month study period. CONCLUSION: A COC with E2V and DNG was shown to 
      provide effective contraception in women aged 18-35 years in North America.
FAU - Nelson, Anita
AU  - Nelson A
AD  - 1 Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center , Torrance, 
      California.
FAU - Parke, Susanne
AU  - Parke S
FAU - Mellinger, Uwe
AU  - Mellinger U
FAU - Zampaglione, Edio
AU  - Zampaglione E
FAU - Schmidt, Anja
AU  - Schmidt A
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20131126
PL  - United States
TA  - J Womens Health (Larchmt)
JT  - Journal of women's health (2002)
JID - 101159262
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Drug Combinations)
RN  - 0 (estradiol valerate-dienogest)
RN  - 4TI98Z838E (Estradiol)
RN  - 6PG9VR430D (Nandrolone)
SB  - IM
CIN - J Womens Health (Larchmt). 2014 Mar;23(3):195-6. PMID: 24528194
MH  - Adolescent
MH  - Adult
MH  - Canada
MH  - Contraception/*methods
MH  - Contraceptives, Oral, Combined/administration & dosage/*adverse effects
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Estradiol/administration & dosage/adverse effects/*analogs & derivatives
MH  - Female
MH  - Humans
MH  - Menstrual Cycle/drug effects
MH  - Nandrolone/administration & dosage/adverse effects/*analogs & derivatives
MH  - Ovulation Inhibition/*drug effects
MH  - Pregnancy
MH  - Treatment Outcome
MH  - United States
MH  - Young Adult
EDAT- 2013/11/28 06:00
MHDA- 2014/05/13 06:00
CRDT- 2013/11/28 06:00
PHST- 2013/11/28 06:00 [entrez]
PHST- 2013/11/28 06:00 [pubmed]
PHST- 2014/05/13 06:00 [medline]
AID - 10.1089/jwh.2013.4320 [doi]
PST - ppublish
SO  - J Womens Health (Larchmt). 2014 Mar;23(3):204-10. doi: 10.1089/jwh.2013.4320. 
      Epub 2013 Nov 26.