Safety, tolerance and acceptability of the Invisible Condom and its vaginal applicator in healthy women and their male sexual partners.
OBJECTIVE
The study was conducted to evaluate the safety and acceptability of the Invisible Condom when applied once or twice daily for 14 days in healthy women and their male sexual partners.


METHODS
Forty-one women and 23 men divided into three cohorts were enrolled. Cohort 1:14 sexually abstinent women applying gel twice daily for 14 days; Cohort 2:14 sexually active women with tubal ligation applying gel once daily for 14 days and their 14 sexual partners who did not use gel; Cohort 3:13 women on oral contraceptive applying gel once daily for 14 days and 9 of their sexual partners.


RESULTS
No serious adverse events (AEs) were reported. Colposcopy showed no genital ulceration nor epithelial lesions. No major changes in vaginal flora or vaginal pH were detected. None of the women had to stop product application because of AEs. The majority of AEs were mild. Common AEs were itching, dryness, burning sensation, erythema and discharge. Satisfaction questionnaire showed that the gel and applicator were acceptable.


CONCLUSIONS
The Invisible Condom and applicator were safe, well tolerated and acceptable when applied intravaginally for 14 days. Thus, expanded safety and effectiveness evaluation is warranted.
Trottier
Sylvie
S
Infectious Diseases Research Centre, Université Laval, Québec, QC, Canada G1V 4G2.
Omar
Rabeea F
RF
Désormeaux
André
A
Drouin
Jean
J
Gagnon
Marie-Thérèse
MT
Vezina
Francine
F
Guilbert
Edith
E
Mâsse
Benoît
B
Bergeron
Michel G
MG
D000282:Administration, Intravaginal; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000009:adverse effects* / Q000032:analysis; D003276:Contraceptives, Oral; D016503:Drug Delivery Systems / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D008297:Male; D012725:Sexual Behavior; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D012967:Sodium Dodecyl Sulfate / Q000008:administration & dosage / Q000009:adverse effects* / Q000032:analysis; D013081:Sperm Motility / Q000187:drug effects; D013094:Spermatozoa / Q000187:drug effects; D013246:Sterilization, Tubal; D014621:Vagina / Q000737:chemistry / Q000187:drug effects / Q000382:microbiology
D000891:Anti-Infective Agents, Local; D003276:Contraceptives, Oral; D012967:Sodium Dodecyl Sulfate