title: Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial.
abstract: OBJECTIVE
  Women need products that protect against both pregnancy and sexually transmitted infections, including human immunodeficiency virus (HIV). The acid buffering gel is a nondetergent spermicide that may provide this dual protection by reinforcing normal vaginal acidity to inactivate both sperm and acid-sensitive sexually transmitted pathogens. The objective of this study was to assess the gel's contraceptive effects, safety, and acceptability.
  
  
  METHODS
  We conducted a multicenter, randomized, double-masked, noninferiority study at 11 centers, comparing 621 women who used an acid buffering gel plus diaphragm with 300 women who used a nonoxynol-9 spermicide plus diaphragm for 6 months. A double-masked study extension followed 234 women for an additional 6 months of use.
  
  
  RESULTS
  The 6-month pregnancy rate per hundred women was 10.1% (95% confidence interval [CI] 7.1-13.1%) for acid buffering gel and 12.3 (95% CI 7.7-16.9) for nonoxynol-9 spermicide users. The difference in rates was -2.2% with a 95% CI -7.7 to 3.3%. Consistent and correct use 6-month pregnancy rates were 4.7% for acid buffering gel and 6.1% for nonoxynol-9 spermicide users, calculated from those cycles where diary entries indicated such use. Adverse events and acceptability were similar between the two groups. Pregnancy probabilities were similar between groups participating in the 12-month study extension.
  
  
  CONCLUSIONS
  An acid buffering gel used with a diaphragm is a safe, acceptable contraceptive with efficacy comparable to that of a common commercial spermicide with diaphragm.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00065858
  
  
  METHODS
  I.
authors.affiliation: University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. Kbarnhart@obgyn.upenn.edu
authors.forename: Kurt T
authors.initials: KT
authors.lastname: Barnhart
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rosenberg
authors.forename: H Trent
authors.initials: HT
authors.lastname: MacKay
authors.forename: Diana L
authors.initials: DL
authors.lastname: Blithe
authors.forename: Jim
authors.initials: J
authors.lastname: Higgins
authors.forename: Terri
authors.initials: T
authors.lastname: Walsh
authors.forename: Livia
authors.initials: L
authors.lastname: Wan
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
authors.forename: Carolyn
authors.initials: C
authors.lastname: Westhoff
authors.forename: William
authors.initials: W
authors.lastname: Schlaff
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.forename: Charletta
authors.initials: C
authors.lastname: Ayers
authors.forename: Andrew
authors.initials: A
authors.lastname: Kaunitz
authors.forename: Sutapa
authors.initials: S
authors.lastname: Das
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Moench
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D003274:Contraceptive Devices, Female / Q000592:standards*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D017137:Nonoxynol / Q000008:administration & dosage; D017060:Patient Satisfaction; D011247:Pregnancy; D018873:Pregnancy Rate; D012449:Safety; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D013089:Spermatocidal Agents / Q000008:administration & dosage*; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000890:Anti-Infective Agents; D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D017137:Nonoxynol