PMID- 32550535
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220415
IS  - 2590-1516 (Electronic)
IS  - 2590-1516 (Linking)
VI  - 2
DP  - 2020
TI  - A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the 
      contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 
      mg using a 24/4-day regimen.
PG  - 100020
LID - 10.1016/j.conx.2020.100020 [doi]
LID - 100020
AB  - OBJECTIVES: To evaluate contraceptive effectiveness and safety of oral 
      drospirenone 4 mg 24/4-day regimen in the United States. STUDY DESIGN: We 
      performed a prospective, single-arm, multicenter phase 3 trial in sexually active 
      women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl 
      index, calculated using confirmed on-drug pregnancies and evaluable cycles in 
      nonbreastfeeding women aged </= 35 years. We assessed adverse events (AEs), 
      including hyperkalemia and venous thromboembolism. RESULTS: Of 1006 women who 
      received at least one dose of drospirenone, 352 women (35.0%) completed the trial 
      and 654 (65.0%) women discontinued before trial end. Most participants (92.2%) 
      were </= 35 years; one third had a body mass index (BMI) >/= 30 kg/m(2). Among 
      nonbreastfeeding women aged </= 35 years, there were 17 pregnancies (Pearl index: 
      4.0; 95% confidence interval [CI], 2.3-6.4; n = 953), of which three were 
      unconfirmed and two were from sites excluded from the main analysis for major 
      breaches of Food and Drug Administration regulations. The Pearl index was 2.9 
      (95% CI: 1.5-5.1) for confirmed pregnancies among 915 nonbreastfeeding women aged 
      </= 35 years from sites with no protocol violations. Nearly all (95.4%) 
      treatment-emergent AEs were mild or moderate in intensity. No cases of venous 
      thromboembolism were reported. The frequency of hyperkalemia was 0.5%. Women with 
      baseline systolic/diastolic blood pressure >/= 130/85 mmHg had a mean reduction 
      from baseline in blood pressure at exit visit (- 8.5/- 4.9 mmHg; n = 119). No 
      other clinically relevant changes were observed. Participant satisfaction was 
      high. CONCLUSION: Drospirenone 4 mg 24/4 regimen provides effective contraception 
      with a good safety/tolerability profile in a broad group of women, including 
      overweight or obese women. IMPLICATIONS: This new progestin-only contraceptive, 
      drospirenone 4 mg in a 24/4 regimen, provides a contraceptive option for the 
      majority of women regardless of blood pressure or BMI.
CI  - (c) 2020 The Authors.
FAU - Kimble, Thomas
AU  - Kimble T
AD  - Eastern Virginia Medical School, Norfolk, VA, USA.
FAU - Burke, Anne E
AU  - Burke AE
AD  - Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine, 
      Baltimore, MD, USA.
FAU - Barnhart, Kurt T
AU  - Barnhart KT
AD  - Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
FAU - Archer, David F
AU  - Archer DF
AD  - Eastern Virginia Medical School, Norfolk, VA, USA.
FAU - Colli, Enrico
AU  - Colli E
AD  - Exeltis, Madrid, Spain.
FAU - Westhoff, Carolyn L
AU  - Westhoff CL
AD  - Department of Obstetrics and Gynecology, and Mailman School of Public Health, 
      Columbia University, New York, NY, USA.
LA  - eng
PT  - Journal Article
DEP - 20200130
PL  - United States
TA  - Contracept X
JT  - Contraception: X
JID - 101767748
PMC - PMC7286157
OTO - NOTNLM
OT  - 24/4-day regimen
OT  - Efficacy
OT  - Progesterone/progestin-only pill
OT  - Safety
OT  - Scheduled bleeding
EDAT- 2020/06/19 06:00
MHDA- 2020/06/19 06:01
PMCR- 2020/01/30
CRDT- 2020/06/19 06:00
PHST- 2019/10/01 00:00 [received]
PHST- 2020/01/16 00:00 [revised]
PHST- 2020/01/21 00:00 [accepted]
PHST- 2020/06/19 06:00 [entrez]
PHST- 2020/06/19 06:00 [pubmed]
PHST- 2020/06/19 06:01 [medline]
PHST- 2020/01/30 00:00 [pmc-release]
AID - S2590-1516(20)30003-4 [pii]
AID - 100020 [pii]
AID - 10.1016/j.conx.2020.100020 [doi]
PST - epublish
SO  - Contracept X. 2020 Jan 30;2:100020. doi: 10.1016/j.conx.2020.100020. eCollection 
      2020.