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document
Study of the vaginal tolerance to Acidform , an acid-buffering , bioadhesive gel . Vaginal tolerance tests were performed with a new potential microbicidal and spermicidal product , an acid-buffering vaginal gel ( Acidform ) without or with nonoxynol-9 ( N-9 ) . The potential advantages over other vaginal products include keeping a low pH , decrease of the irritating effect of N-9 on the cervix or vaginal mucosa associated with greater retention of the product after application , and decreasing " messiness " as compared to other vaginal products . Three groups of six women were admitted and randomly assigned to use Acidform with 0 % , 2.5 % , and 5 % N-9 . Colposcopic evaluation for vulvar , vaginal , and cervical signs of irritation was performed and photographs were taken , following a specific World Health Organization protocol , at time 0 , and after 24 h and 6 days of application of the gel . No irritation or symptom was reported by users of Acidform without N-9 . A generalized and intense erythema in cervix was observed in 10 of 12 Acidform/N-9 users and abrasion occurred in nine of them . Vulvar irritation was seen in seven of these 10 volunteers . N-9 concentration in the gel ( 2.5 % or 5.0 % ) was not related to the findings . No ulcer , exulceration , or de-epithelialization was observed . Acidform without N-9 was well tolerated by volunteers , but it was unable to protect the cervix , vagina , and vulva from the N-9 effects .
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Intervention_Pharmacological
Acidform
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Intervention_Pharmacological
acid-buffering
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Intervention_Pharmacological
bioadhesive gel
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Intervention_Pharmacological
acid-buffering vaginal gel ( Acidform )
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Intervention_Pharmacological
nonoxynol-9 ( N-9 )
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Intervention_Pharmacological
N-9
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Intervention_Pharmacological
Acidform
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Intervention_Pharmacological
N-9
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Intervention_Pharmacological
Acidform without N-9
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Intervention_Pharmacological
Acidform/N-9
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Intervention_Pharmacological
Acidform without N-9
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Outcome_Adverse-effects
No irritation or symptom
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Outcome_Adverse-effects
A generalized and intense erythema in cervix
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Outcome_Adverse-effects
Vulvar irritation
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Outcome_Other
N-9 concentration in the gel
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Outcome_Adverse-effects
No ulcer , exulceration , or de-epithelialization
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Participant_Sample-size
Three groups of six