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

Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Research Abstract Details 

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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. Abstract Text:

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

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.

Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Publishing Authors By Initials

DL Williams,DR Newman,SA Ballagh,MD Creinin,K Barnhart,DH Weiner,AJ Bell,DJ Jamieson,DL Williams,DR Newman,SA Ballagh,MD Creinin,K Barnhart,DH Weiner,AJ Bell,DJ Jamieson,

For similar bacterial infections and mycoses: bacterial infections: vaginosis, bacterial research abstracts see: bacterial infections and mycoses: bacterial infections: vaginosis, bacterial research

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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 Published:

PUBLICATION TYPE: Research Support, U.S. Gov't,

Journal: Sexually transmitted diseases

VOLUME: 34

Page Numbers: 977-84

Journal Abbreviation:

ISSN: 0148-5717

DAY: 17

MONTH: Dec

YEAR: 2007

Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 7705941

Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Keywords Mesh Terms:

KEYWORDS: Vaginosis, Bacterial

MESH TERMS: prevention & control

Chemical & Substance for Abstract: Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Information

Substance Name: Cellulose

Registry Number: 9004-34-6

Grant and Affiliation Information for Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm.

AFFILIATION: CONRAD, Arlington, VA, USA. dlw6@cdc.gov

Country: United States

AGENCY: United States NCRR

GRANT: MO1RR000056

ACRONYM: RR

MEDLINETA: Sex Transm Dis

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