PMID- 27494570
OWN - NLM
STAT- MEDLINE
DCOM- 20170503
LR  - 20170503
IS  - 1473-0782 (Electronic)
IS  - 1362-5187 (Linking)
VI  - 21
IP  - 5
DP  - 2016 Oct
TI  - A multicentre, open-label, randomised phase III study comparing a new 
      levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combined oral 
      contraception in young women of reproductive age.
PG  - 372-9
LID - 10.1080/13625187.2016.1212987 [doi]
AB  - OBJECTIVES: To compare user satisfaction and adverse events (AEs) with a 
      levonorgestrel intrauterine system (LNG-IUS 8; average levonorgestrel release 
      rate approximately 8 mug/24 h over the first year [total content 13.5 mg]) and a 
      30 mug ethinyl estradiol/3 mg drospirenone (EE/DRSP) combined oral contraceptive 
      (COC) in a population of young women. METHODS: Nulliparous and parous women (aged 
      18-29 years) with regular menstrual cycles (21-35 days) were randomised to 
      LNG-IUS 8 or EE/DRSP for 18 months. The primary endpoint was the overall user 
      satisfaction rate at month 18/end of study visit. RESULTS: Overall, 279 women 
      were randomised to LNG-IUS 8 with attempted placement and 281 women were 
      randomised to EE/DRSP and took >/=1 pill; the mean age was 23.7 and 23.9 years, and 
      77.4% and 73.3% were nulliparous, respectively. At month 18/end of study, 82.1% 
      and 81.9% of women, respectively, reported being 'very satisfied' or 'satisfied' 
      with their treatment; however, significantly more LNG-IUS 8 users reported a 
      preference to continue their treatment post-study (66.2% vs 48.8%; p = 0.0001). 
      There were two pregnancies (one ectopic pregnancy, one spontaneous abortion) 
      reported in the LNG-IUS 8 group and six (three live births, two spontaneous 
      abortions, one induced abortion) in the EE/DRSP group. CONCLUSIONS: LNG-IUS 8 and 
      EE/DRSP were associated with similarly high user satisfaction rates. However, 
      LNG-IUS 8 users were significantly more likely to prefer to continue their 
      contraceptive method post-study, indicating that a levonorgestrel intrauterine 
      system is an appealing contraceptive option for young women.
FAU - Borgatta, Lynn
AU  - Borgatta L
AD  - a Department of Obstetrics and Gynecology , Boston University School of Medicine 
      , Boston , MA , USA ;
FAU - Buhling, Kai J
AU  - Buhling KJ
AD  - b Department of Gynecological Endocrinology , University Hospital 
      Hamburg-Eppendorf , Hamburg , Germany ;
FAU - Rybowski, Sarah
AU  - Rybowski S
AD  - c Bayer HealthCare Pharmaceuticals , Whippany , NJ , USA ;
FAU - Roth, Katrin
AU  - Roth K
AD  - d Bayer Pharma AG , Berlin , Germany.
FAU - Rosen, Kimberly
AU  - Rosen K
AD  - c Bayer HealthCare Pharmaceuticals , Whippany , NJ , USA ;
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160805
PL  - England
TA  - Eur J Contracept Reprod Health Care
JT  - The European journal of contraception & reproductive health care : the official 
      journal of the European Society of Contraception
JID - 9712127
RN  - 0 (Androstenes)
RN  - 0 (Contraceptive Agents, Female)
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (drospirenone and ethinyl estradiol combination)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Androstenes/*therapeutic use
MH  - Austria
MH  - Belgium
MH  - Contraceptive Agents, Female/therapeutic use
MH  - Contraceptives, Oral, Combined/*therapeutic use
MH  - Ethinyl Estradiol/*therapeutic use
MH  - Female
MH  - Germany
MH  - Humans
MH  - *Intrauterine Devices, Medicated
MH  - Levonorgestrel/*therapeutic use
MH  - Patient Satisfaction
MH  - United States
MH  - Young Adult
OTO - NOTNLM
OT  - Combined oral contraception
OT  - LARC
OT  - LNG-IUS
OT  - intrauterine contraception
OT  - intrauterine system
OT  - long-acting reversible contraception
EDAT- 2016/08/06 06:00
MHDA- 2017/05/04 06:00
CRDT- 2016/08/06 06:00
PHST- 2016/08/06 06:00 [entrez]
PHST- 2016/08/06 06:00 [pubmed]
PHST- 2017/05/04 06:00 [medline]
AID - 10.1080/13625187.2016.1212987 [doi]
PST - ppublish
SO  - Eur J Contracept Reprod Health Care. 2016 Oct;21(5):372-9. doi: 
      10.1080/13625187.2016.1212987. Epub 2016 Aug 5.