Phase I safety trial of two vaginal microbicide gels (acidform or bufferGel) used with a diaphragm compared to KY jelly used with a diaphragm

Dnyce L Williams; Daniel R Newman; Susan A Ballagh; Mitchell D Creinin; Kurt Barnhart; Debra H Weiner; April J Bell; Denise J Jamieson

doi:10.1097/OLQ.0b013e31813347e9

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Phase I safety trial of two vaginal microbicide gels (acidform or bufferGel) used with a diaphragm compared to KY jelly used with a diaphragm

Journal article

Open access

Peer reviewed

Phase I safety trial of two vaginal microbicide gels (acidform or bufferGel) used with a diaphragm compared to KY jelly used with a diaphragm

Dnyce L Williams, Daniel R Newman, Susan A Ballagh, Mitchell D Creinin, Kurt Barnhart, Debra H Weiner, April J Bell and Denise J Jamieson

Sexually transmitted diseases, Vol.34(12), pp.977-984

12/01/2007

DOI: 10.1097/OLQ.0b013e31813347e9

PMID: 18080349

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Abstract

Objectives: To assess the safety and acceptability of 2 vaginal microbicide gels (Acidform and BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm among low-risk, sexually abstinent women. Study Design: Eighty-one women enrolled in a randomized, masked, phase I safety study using a diaphragm with Acidform, BufferGel, or KY Jelly for 6 to 10 hours nightly for 14 nights. Physical examination, colposcopy, and lab studies were performed after 1 and 2 weeks of use. Diaries and questionnaires were used to assess user acceptability. Results: Sixty-nine participants (85%) completed the study. Safety and acceptability appeared similar among the 3 study groups and no serious adverse events related to the study products were reported. Adverse events were mild and anticipated. Conclusions: Acidform and BufferGel compared to KY Jelly, when used with diaphragm daily for 14 days, appeared to be safe and acceptable in a small study of low-risk abstinent women.

Infectious Diseases

Biological and medical sciences

Epidemiology. Vaccinations

General aspects

Human infectious diseases. Experimental studies and models

Medical sciences

Details

Title: Subtitle: Phase I safety trial of two vaginal microbicide gels (acidform or bufferGel) used with a diaphragm compared to KY jelly used with a diaphragm
Creators: Dnyce L Williams - CONRAD, Arlington, VA, United States
Daniel R Newman - Centers for Disease Control and Prevention
Susan A Ballagh - Eastern Virginia Medical School
Mitchell D Creinin - University of Pittsburgh
Kurt Barnhart - University of Pennsylvania
Debra H Weiner - Family Health International, Research Triangle Park, North Carolina, United States
April J Bell - Centers for Disease Control and Prevention
Denise J Jamieson - Centers for Disease Control and Prevention
Resource Type: Journal article
Publication Details: Sexually transmitted diseases, Vol.34(12), pp.977-984
Publisher: Lippincott
DOI: 10.1097/OLQ.0b013e31813347e9
PMID: 18080349
ISSN: 0148-5717
eISSN: 1537-4521
Language: English
Date published: 12/01/2007
Academic Unit: Obstetrics and Gynecology; VPMA - Administration
Record Identifier: 9984446435202771

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