title: A randomized noninferiority crossover controlled trial of the functional performance and safety of new female condoms: an evaluation of the Velvet, Cupid2, and FC2.
abstract: OBJECTIVE
  New designs of female condoms have been developed to lower cost and/or improve acceptability. To secure regulatory approvals, clinical studies are required to verify performance. We aimed to assess the functional performance and safety of two new female condom types - Velvet and Cupid2 female condom - against the existing FC2 female condom.
  
  
  METHODS
  This was a three-period crossover, randomized noninferiority clinical trial with 300 women randomized to condom-type order in one South African site. Primary end points were total clinical failure and total female condom failure. Noninferiority of component modes, clinical breakage, nonclinical breakage, slippage, misdirection and invagination were also determined. Safety data were also assessed for each female condom. Participants were asked to use five of each female condom type and to collect information on use in a condom diary at home and were interviewed after use of each type. Frequencies and percentages were calculated by condom type for each failure mode, and differences in performance of the three female condoms using FC2 as reference, with 95% confidence intervals, were estimated using generalized estimating equation models.
  
  
  RESULTS
  A total of 282 (94%) participants completed follow-up, using at least one condom of each type. Total clinical failure (clinical breakage, invagination, misdirection, slippage) was <5% for all female condoms: FC2 (4.50%), Cupid2 (4.79%) and Velvet (3.93%). Noninferiority was demonstrated for all condom failure modes for the two new female condoms with respect to FC2, within the margin of 3% difference in mean failure, at the 5% significance level.
  
  
  CONCLUSIONS
  Noninferiority for the two new female condoms was demonstrated with respect to the marketed FC2. These data are used to support manufacturer dossiers for World Health Organization (WHO)/United Nations Population Fund (UNFPA) prequalification.
  
  
  CONCLUSIONS
  Data from this study have been submitted to WHO/UNFPA and will contribute to the prequalification submission requirements for the Cupid2 and Velvet female condoms.
authors.affiliation: MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, 34 Essex Terrace, Westville, Durban 3629, South Africa; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E, UK. Electronic address: mags.beksinska@lshtm.ac.uk.
authors.forename: Mags
authors.initials: M
authors.lastname: Beksinska
authors.affiliation: MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, 34 Essex Terrace, Westville, Durban 3629, South Africa.
authors.forename: Ross
authors.initials: R
authors.lastname: Greener
authors.affiliation: Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E, UK.
authors.forename: Immo
authors.initials: I
authors.lastname: Kleinschmidt
authors.affiliation: MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, 34 Essex Terrace, Westville, Durban 3629, South Africa.
authors.forename: Lavanya
authors.initials: L
authors.lastname: Pillay
authors.affiliation: MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, 34 Essex Terrace, Westville, Durban 3629, South Africa.
authors.forename: Virginia
authors.initials: V
authors.lastname: Maphumulo
authors.affiliation: MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, 34 Essex Terrace, Westville, Durban 3629, South Africa; School of Pharmacy and Pharmacology, Faculty of Health Sciences, University of KwaZulu-Natal, University Road, Chiltern Hills, Westville 3629, South Africa.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Smit
mesh_terms: D000293:Adolescent; D000328:Adult; D019111:Single-Use Internal Condom / Q000009:adverse effects* / Q000145:classification*; D042121:Contraception, Barrier / Q000379:methods*; D018592:Cross-Over Studies; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D057566:Self Report; D013019:South Africa; D055815:Young Adult
keywords: Barrier methods; Female condom; Function; Safety