title: A randomized, double-blind, placebo-controlled safety and acceptability study of two Invisible Condom formulations in women from Cameroon.
abstract: BACKGROUND
  The objectives of this clinical trial were to evaluate the safety, tolerance and acceptability of two gel formulations of the Invisible Condom: (i) the polymer alone and (ii) the polymer-containing sodium lauryl sulfate (SLS) compared to placebo when applied intravaginally with our unique applicator in sexually abstinent and active woman volunteers.
  
  
  METHODS
  A randomized, doubled-blind, placebo-controlled study in healthy women from Yaoundé, Cameroon. Two hundred sixty women were randomized into three gel arms: (a) gel alone, (b) gel plus SLS and (c) placebo gel. Thirty-seven sexually abstinent women applied gel intravaginally once a day for 14 days, while 75, 74 and 74 sexually active women applied gel intravaginally once, twice or three times daily for 14 days, respectively.
  
  
  RESULTS
  Retention rate was high at 85% and 221 women applied the two products and the placebo for a total of 6005 times. Nugent score, H(2)O(2)-producing lactobacilli and vaginal pH were stable throughout the study and were not affected by the study products. Colposcopy showed neither genital ulceration nor mucosal lesions. No study product-related serious adverse events were reported. The majority of reported adverse events were mild or moderate and largely similar in all 3 arms. Satisfaction questionnaire showed that the gel formulations and applicator were generally comfortable and acceptable.
  
  
  CONCLUSIONS
  The Invisible Condom formulations and applicator were found to be comfortable, well tolerated and acceptable when applied intravaginally once, twice or thrice daily for 14 days. Thus, expanded safety evaluation is warranted.
authors.affiliation: Laboratoire de Santé Hygiène Mobile, Ministry of Public Health and Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.
authors.forename: Francois-Xavier
authors.initials: FX
authors.lastname: Mbopi-Keou
authors.forename: Sylvie
authors.initials: S
authors.lastname: Trottier
authors.forename: Rabeea F
authors.initials: RF
authors.lastname: Omar
authors.forename: Ngoh N
authors.initials: NN
authors.lastname: Nkele
authors.forename: Séraphin
authors.initials: S
authors.lastname: Fokoua
authors.forename: Enow R
authors.initials: ER
authors.lastname: Mbu
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Giguere
authors.forename: Marc-Christian
authors.initials: MC
authors.lastname: Domingo
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Piret
authors.forename: Landry
authors.initials: L
authors.lastname: Tsague
authors.forename: Leopold
authors.initials: L
authors.lastname: Zekeng
authors.forename: Anthony
authors.initials: A
authors.lastname: Mwatha
authors.forename: Benoît
authors.initials: B
authors.lastname: Mâsse
authors.forename: Michel G
authors.initials: MG
authors.lastname: Bergeron
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects; D002163:Cameroon; D002584:Cervix Uteri / Q000473:pathology*; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011060:Poloxalene / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D012747:Sexual Partners / Q000523:psychology; D012749:Sexually Transmitted Diseases / Q000517:prevention & control / Q000635:transmission; D012967:Sodium Dodecyl Sulfate / Q000008:administration & dosage / Q000009:adverse effects; D011795:Surveys and Questionnaires; D014621:Vagina / Q000382:microbiology* / Q000473:pathology; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D005782:Gels; D014622:Vaginal Creams, Foams, and Jellies; D012967:Sodium Dodecyl Sulfate; D011060:Poloxalene