PMID- 17656181
OWN - NLM
STAT- MEDLINE
DCOM- 20080103
LR  - 20131121
IS  - 0010-7824 (Print)
IS  - 0010-7824 (Linking)
VI  - 76
IP  - 2
DP  - 2007 Aug
TI  - Safety, tolerance and acceptability of the Invisible Condom and its vaginal 
      applicator in healthy women and their male sexual partners.
PG  - 117-25
AB  - OBJECTIVES: 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. STUDY DESIGN: 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. CONCLUSION: 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.
FAU - Trottier, Sylvie
AU  - Trottier S
AD  - Infectious Diseases Research Centre, Universite Laval, Quebec, QC, Canada G1V 
      4G2.
FAU - Omar, Rabeea F
AU  - Omar RF
FAU - Desormeaux, Andre
AU  - Desormeaux A
FAU - Drouin, Jean
AU  - Drouin J
FAU - Gagnon, Marie-Therese
AU  - Gagnon MT
FAU - Vezina, Francine
AU  - Vezina F
FAU - Guilbert, Edith
AU  - Guilbert E
FAU - Masse, Benoit
AU  - Masse B
FAU - Bergeron, Michel G
AU  - Bergeron MG
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20070622
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Anti-Infective Agents, Local)
RN  - 0 (Contraceptives, Oral)
RN  - 368GB5141J (Sodium Dodecyl Sulfate)
SB  - IM
MH  - Administration, Intravaginal
MH  - Anti-Infective Agents, Local/administration & dosage/*adverse effects/analysis
MH  - Contraceptives, Oral
MH  - Drug Delivery Systems/*adverse effects
MH  - Female
MH  - Humans
MH  - Hydrogen-Ion Concentration/drug effects
MH  - Male
MH  - *Sexual Behavior
MH  - Sexually Transmitted Diseases/*prevention & control
MH  - Sodium Dodecyl Sulfate/administration & dosage/*adverse effects/analysis
MH  - Sperm Motility/drug effects
MH  - Spermatozoa/drug effects
MH  - Sterilization, Tubal
MH  - Vagina/chemistry/drug effects/microbiology
EDAT- 2007/07/28 09:00
MHDA- 2008/01/04 09:00
CRDT- 2007/07/28 09:00
PHST- 2007/01/28 00:00 [received]
PHST- 2007/04/02 00:00 [revised]
PHST- 2007/04/26 00:00 [accepted]
PHST- 2007/07/28 09:00 [pubmed]
PHST- 2008/01/04 09:00 [medline]
PHST- 2007/07/28 09:00 [entrez]
AID - S0010-7824(07)00197-7 [pii]
AID - 10.1016/j.contraception.2007.04.015 [doi]
PST - ppublish
SO  - Contraception. 2007 Aug;76(2):117-25. doi: 10.1016/j.contraception.2007.04.015. 
      Epub 2007 Jun 22.