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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.

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

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  1. 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

  2. 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)

  3. 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)

  4. 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.

  5. 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

  6. 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)

  7. Baseline Characteristics

  8. Efficacy

  9. Infectionscumulative through cycle 6

  10. Colposcopic Lesions Average # of lesions/woman at follow-up 0.73 1.07 0.2

  11. Side Effects

  12. Acceptability at Cycle 6

  13. 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

  14. 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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