buffergel with diaphragm found to be an effective contraceptive in two phase ii iii trials
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BufferGel® with diaphragm found to be an effective contraceptive in two Phase II/III trials. Kurt T Barnhart, MD MSCE; Univ. of Pennsylvania James E Higgins; Health Decisions, Inc. H Trent MacKay, MD MPH; NICHD Diana L Blithe, PhD; NICHD Thomas R Moench, MD; ReProtect, Inc.

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buffergel with diaphragm found to be an effective contraceptive in two phase ii iii trials
BufferGel® with diaphragm found to be an effective contraceptive in two Phase II/III trials

Kurt T Barnhart, MD MSCE; Univ. of Pennsylvania

James E Higgins; Health Decisions, Inc.

H Trent MacKay, MD MPH; NICHD

Diana L Blithe, PhD; NICHD

Thomas R Moench, MD; ReProtect, Inc.

for the NICHD Contraceptive Clinical Trials Network

nichd contraceptive clinical trials investigators
NICHD Contraceptive Clinical Trials Investigators
  • California Family Health Council, UCLA, Harbor-UCLA Medical Center: A. Nelson, R. Frezieres, T. Walsh
  • Columbia University: C. Westhoff
  • Eastern Virginia Medical School: D. Archer
  • Magee-Womens Hospital: M. Creinin
  • New York University: L. Wan
  • University of Cincinnati: M. Thomas
  • University of Colorado Health Sciences Center: W. Schlaff
  • University of Florida Health Science Center: A. Kaunitz
  • University of Medicine and Dentistry of New Jersey: C. Ayers
  • University of Pennsylvania: K. Barnhart

NICHD, National Institutes of Health, Contract Numbers N01-HD-6-3261, N01-HD-1-33(14-20)

buffergel
BufferGel
  • Non-detergent spermicidal microbicide
  • Potent acidic buffering capacity
  • Reinforces normal vaginal acidity to inactivate sperm and sexually transmitted infection pathogens
  • Currently also under investigation in Phase II/IIB for prevention of HIV transmission (HPTN 035)
study design rationale
Study Design Rationale
  • BufferGel is a spermicidal microbicide, being developed for dual protection (disease and pregnancy).
  • Diaphragms may increase protection against disease as well as pregnancy. (e.g., MIRA trial hypothesis)
  • Therefore BufferGel and N9, each with a diaphragm, were compared for contraceptive effectiveness.
ccn003
CCN003

PRIMARY HYPOTHESIS

BufferGel® used with diaphragm is non-inferior to Gynol II® used with diaphragm for contraceptive efficacy.

SECONDARY OUTCOMES

Safety of BufferGel with diaphragm: (vaginal and urinary tract infections, genital irritation, and colposcopic lesions)

Acceptability of BufferGel with diaphragm

study design
Study Design
  • Study One
    • Double-blind, randomized 2:1 BufferGel to Gynol II
  • Study Two
    • Open-label BufferGel
  • Subjects used product for 6 cycles (both studies)
  • Those completing Study One could elect to continue for an additional 6 cycles (total of 12 cycles)
colposcopic lesions
Colposcopic Lesions

Average # of lesions/woman

at follow-up

0.73 1.07 0.2

summary
Summary
  • BufferGel displayed a 6-month typical use pregnancy rate of 10.1
  • Side effects were similar in both groups, with fewer symptomatic urinary tract infections in the BufferGel group
  • 68% of subjects using BufferGel would definitely or probably use it if it were available
conclusion
Conclusion
  • BufferGel used with a diaphragm is a safe, acceptable contraceptive with efficacy that is non-inferior to Gynol II used with a diaphragm
  • Evaluation for HIV prevention is ongoing (HPTN 035)
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