PMID- 32685920
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220415
IS  - 2590-1516 (Electronic)
IS  - 2590-1516 (Linking)
VI  - 2
DP  - 2020
TI  - A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception 
      clinical trial.
PG  - 100031
LID - 10.1016/j.conx.2020.100031 [doi]
LID - 100031
AB  - OBJECTIVE: The objective was to evaluate the contraceptive effectiveness, safety, 
      and acceptability of a novel vaginal pH regulator over seven cycles of use. STUDY 
      DESIGN: A single-arm, open-label, phase 3 study was conducted across 112 sites in 
      the United States in sexually active 18-35-year-old women at risk of pregnancy. 
      Women administered the study treatment </= 1 h before each episode of intercourse. 
      Women recorded use of study drug, coital information, and any symptoms 
      experienced in electronic diaries. The primary outcome was the seven-cycle 
      cumulative pregnancy rate as calculated using the Kaplan-Meier methodology; 
      secondary outcomes included safety. Overall satisfaction was assessed via written 
      questionnaires. RESULTS: A total of 1384 women were enrolled in the study from 
      July 2017 to November 2018. Mean age was 27.7 +/- 4.4 years; most women were white 
      (69.0%). The seven-cycle cumulative pregnancy percentage was 13.7% [95% 
      confidence interval (CI): 10.0%-17.5%], meeting the prespecified primary endpoint 
      of having the upper bound 95% CI </= 21%. Most common adverse events (AEs) 
      occurring in >/= 2% of women were vulvovaginal burning sensation, vulvovaginal 
      pruritus, urinary tract infection, vulvovaginal pain, mycotic infection, 
      bacterial vaginosis, and nasopharyngitis. Of 1330 women who used the study drug 
      at least once, fewer than 2% of women discontinued due to any AEs, and < 1% of 
      women discontinued due to genitourinary symptoms. Overall, > 80% of women 
      reported being "very satisfied" or "satisfied" with study treatment. CONCLUSIONS: 
      In this phase 3 study, the novel vaginal pH regulator demonstrated 86.3% 
      contraceptive effectiveness, was safe and well tolerated, and was highly 
      acceptable. IMPLICATIONS: This novel vaginal pH regulator is a safe, nonhormonal, 
      woman-controlled method of contraception that expands women's options.
CI  - (c) 2020 The Authors.
FAU - Thomas, Michael A
AU  - Thomas MA
AD  - University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45219, USA.
FAU - Chappell, B Todd
AU  - Chappell BT
AD  - Adams Patterson Gynecology & Obstetrics, 1727 Kirby Parkway, Memphis, TN, 38210, 
      USA.
FAU - Maximos, Bassem
AU  - Maximos B
AD  - Maximos Obstetrics and Gynecology, 651 Egret Bay Boulevard, League City, TX, 
      77573, USA.
FAU - Culwell, Kelly R
AU  - Culwell KR
AD  - Evofem Biosciences, Inc., 12400 High Bluff Drive, Suite 600, San Diego, CA, 
      92130, USA.
FAU - Dart, Clint
AU  - Dart C
AD  - Health Decisions, 2510 Meridian Parkway, Durham, NC, 27713, USA.
FAU - Howard, Brandon
AU  - Howard B
AD  - Evofem Biosciences, Inc., 12400 High Bluff Drive, Suite 600, San Diego, CA, 
      92130, USA.
LA  - eng
PT  - Journal Article
DEP - 20200701
PL  - United States
TA  - Contracept X
JT  - Contraception: X
JID - 101767748
PMC - PMC7358659
OTO - NOTNLM
OT  - Contraception
OT  - Nonhormonal
OT  - Phase 3 trial
OT  - Vaginal gel
EDAT- 2020/07/21 06:00
MHDA- 2020/07/21 06:01
PMCR- 2020/07/01
CRDT- 2020/07/21 06:00
PHST- 2020/03/24 00:00 [received]
PHST- 2020/06/18 00:00 [revised]
PHST- 2020/06/21 00:00 [accepted]
PHST- 2020/07/21 06:00 [entrez]
PHST- 2020/07/21 06:00 [pubmed]
PHST- 2020/07/21 06:01 [medline]
PHST- 2020/07/01 00:00 [pmc-release]
AID - S2590-1516(20)30014-9 [pii]
AID - 100031 [pii]
AID - 10.1016/j.conx.2020.100031 [doi]
PST - epublish
SO  - Contracept X. 2020 Jul 1;2:100031. doi: 10.1016/j.conx.2020.100031. eCollection 
      2020.