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

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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)


Baseline characteristics

Baseline Characteristics


Efficacy

Efficacy


Infections cumulative through cycle 6

Infectionscumulative through cycle 6


Colposcopic lesions

Colposcopic Lesions

Average # of lesions/woman

at follow-up

0.73 1.07 0.2


Side effects

Side Effects


Acceptability at cycle 6

Acceptability at Cycle 6


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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