title: Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial.
abstract: BACKGROUND
  New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types-the Woman's Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2).
  
  
  METHODS
  We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China, and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18-45 years who were sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients (1:1:1:1) to the FC2 control device, or the Woman's, VA wow, or Cupid condoms, with 12 potential allocations. Randomisation was stratified by site. Participants were not masked to condom type, but allocation was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female condom failure, with a non-inferiority margin of 3%. Women were asked to use five of each condom type and were interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-treat analyses. We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271.
  
  
  RESULTS
  616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120, and 150 women in the three sites in China, and 300 women in the site in South Africa). 572 women completed follow-up, with at least one condom of each type. Total female condom failure was 3·43% for FC2, 3·85% for the Woman's Condom (difference 0·42%, 90% CI -1·42 to 2·26), 3·02% for VA wow (-0·42%, -1·86 to 1·32), and 4·52% for Cupid (1·09%, -0·60 to 2·78); total clinical failure was 2·88%, 3·05% (0·17%, -1·48 to 1·81), 2·49% (-0·25%, -1·75 to 1·26), and 3·87% (0·99%, -0·55 to 2·52), respectively. Only two (<1%) participants, in South Africa, reported serious adverse events, unrelated to use of the study products.
  
  
  CONCLUSIONS
  Non-inferiority was shown for all condom failure events for the three new devices versus the FC2, within the predefined margin.
  
  
  BACKGROUND
  Universal Access to Female Condoms (UAFC).
authors.affiliation: Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: mbeksinska@match.org.za.
authors.forename: Mags E
authors.initials: ME
authors.lastname: Beksinska
authors.affiliation: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Gilda
authors.initials: G
authors.lastname: Piaggio
authors.affiliation: Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; School of Pharmacy and Pharmacology, Faculty of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Smit
authors.affiliation: Department of Epidemiology and Social Science on Reproductive Health, Shanghai Institute of Planned Parenthood Research, Fudan University, Shanghai, China.
authors.forename: Junqing
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Epidemiology and Social Science on Reproductive Health, Shanghai Institute of Planned Parenthood Research, Fudan University, Shanghai, China.
authors.forename: Yufeng
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Pienaar
authors.affiliation: Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Ross
authors.initials: R
authors.lastname: Greener
authors.affiliation: Department of Epidemiology and Social Science on Reproductive Health, Shanghai Institute of Planned Parenthood Research, Fudan University, Shanghai, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Joanis Consulting, Kennesaw, GA. USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Joanis
mesh_terms: D000293:Adolescent; D000328:Adult; D002681:China; D019111:Single-Use Internal Condom; D018592:Cross-Over Studies; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D017060:Patient Satisfaction; D013019:South Africa; D055815:Young Adult