Obstetrics & Gynecology Email Alerts
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Obstetrics & Gynecology 2007;110:577-586
© 2007 by The American College of Obstetricians and Gynecologists
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Barnhart, K. T.
Right arrow Articles by Moench, T. R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Barnhart, K. T.
Right arrow Articles by Moench, T. R.
Related Collections
Right arrow Contraception

ORIGINAL RESEARCH

Contraceptive Efficacy of a Novel Spermicidal Microbicide Used With a Diaphragm

A Randomized Controlled Trial

Kurt T. Barnhart, MD, MSCE1, Michael J. Rosenberg, MD, MPH2, H. Trent MacKay, MD, MPH3, Diana L. Blithe, PhD3, Jim Higgins, PhD2, Terri Walsh, MPH4, Livia Wan, MD5, Michael Thomas, MD6, Mitchell D. Creinin, MD7, Carolyn Westhoff, MD8, William Schlaff, MD9, David F. Archer, MD10, Charletta Ayers, MD11, Andrew Kaunitz, MD12, Sutapa Das, MS2 and Thomas R. Moench, MD13

From the 1University of Pennsylvania, Philadelphia, Pennsylvania; 2Health Decisions, Inc, Chapel Hill, North Carolina; 3National Institute of Child Health and Human Development, Bethesda, Maryland; 4California Family Health Council Los Angeles, California; 5New York University, New York, New York; 6University of Cincinnati, Cincinnati, Ohio; 7University of Pittsburgh and Magee-Women’s Research Institute, Pittsburgh, Pennsylvania; 8Columbia University, New York, New York; 9University of Colorado Health Sciences Center, Denver, Colorado; 10CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia; 11University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey; 12University of Florida Health Science Center, Jacksonville, Florida; and 13ReProtect, Inc, Baltimore, Maryland.

OBJECTIVE: Women need products that protect against both pregnancy and sexually transmitted infections, including human immunodeficiency virus (HIV). The acid buffering gel is a nondetergent spermicide that may provide this dual protection by reinforcing normal vaginal acidity to inactivate both sperm and acid-sensitive sexually transmitted pathogens. The objective of this study was to assess the gel’s contraceptive effects, safety, and acceptability.

METHODS: We conducted a multicenter, randomized, double-masked, noninferiority study at 11 centers, comparing 621women who used an acid buffering gel plus diaphragm with 300 women who used a nonoxynol-9 spermicide plus diaphragm for 6 months. A double-masked study extension followed 234 women for an additional 6 months of use.

RESULTS: The 6-month pregnancy rate per hundred women was 10.1% (95% confidence interval [CI] 7.1–13.1%) for acid buffering gel and 12.3 (95% CI 7.7–16.9) for nonoxynol-9 spermicide users. The difference in rates was –2.2% with a 95% CI –7.7 to 3.3%. Consistent and correct use 6-month pregnancy rates were 4.7% for acid buffering gel and 6.1% for nonoxynol-9 spermicide users, calculated from those cycles where diary entries indicated such use. Adverse events and acceptability were similar between the two groups. Pregnancy probabilities were similar between groups participating in the 12-month study extension.

CONCLUSION: An acid buffering gel used with a diaphragm is a safe, acceptable contraceptive with efficacy comparable to that of a common commercial spermicide with diaphragm.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00065858

LEVEL OF EVIDENCE: I






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2007 by the American College of Obstetricians and Gynecologists.