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University of Pennsylvania School of Medicine BufferGel® with diaphragm found to be an effective contraceptive in two Phase II/III trials Kurt T Barnhart,

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Presentation on theme: "University of Pennsylvania School of Medicine BufferGel® with diaphragm found to be an effective contraceptive in two Phase II/III trials Kurt T Barnhart,"— Presentation transcript:

1 University of Pennsylvania School of Medicine 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 University of Pennsylvania School of Medicine 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 University of Pennsylvania School of Medicine 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 University of Pennsylvania School of Medicine 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 University of Pennsylvania School of Medicine 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 CCN003

6 University of Pennsylvania School of Medicine 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 University of Pennsylvania School of Medicine Baseline Characteristics Characteristics BufferGel (N=621) Gynol II (N=300) Age in years (SD)27.7 (5.8)28.4 (5.8) Race (%) African-American2327 White6058 Asian55 Other139 Hispanic or Latina (%)2017 Never used diaphragm before (%)8082 Never used spermicide before (%)5856 Married (%)3332 Living with partner (%)6866 Nulligravida (%)3329

8 University of Pennsylvania School of Medicine Screened: 1333 Eligible: 1055 BufferGel with diaphragm: 703 All-treated: 621 Used product, pregnancy information available: 615 Perfect use: 438 Discontinued before 6 months: 362 -Pregnancy: 54 -Adverse experience: 22 -Noncompliance: 111 -Lost to follow-up: 78 -Other: 97 Entered 6-month extension: 153 Discontinued before 6 months: 45 -Pregnancy: 8 -Adverse experience: 1 -Noncompliance: 10 -Lost to follow-up: 7 -Other: 19 Gynol II with diaphragm: 352 All-treated: 300 Used product, pregnancy information available: 297 Perfect use: 220 Discontinued before 6 months: 185 -Pregnancy: 29 -Adverse experience: 12 -Noncompliance: 43 -Lost to follow-up: 42 -Other: 59 Entered 6-month extension: 81 Discontinued before 6 months: 18 -Pregnancy: 3 -Adverse experience: 0 -Noncompliance: 5 -Lost to follow-up: 4 -Other: 6

9 University of Pennsylvania School of Medicine Efficacy BufferGelGynol II Difference95% CI Population Pregnancy Probability (%) 95% CI Pregnancy Probability (%) 95% CI 6-mo cumulative probability Intent-to-Treat 10.37.7, 12.811.07.3, 4.6-0.7-5.1, 3.8 Modified Intent-to-Treat 10.17.1, 13.112.37.7, 16.9-2.2-7.7, 3.3 Perfect Use 4.70.9, 8.46.10.2, 12.0-1.4-8.4, 5.6 12-mo cumulative probability Modified Intent-to-Treat 16.710.2, 23.117.08.2, 25.9-0.4-11.3, 10.6 Perfect Use 4.70.0, 14.26.10.0, 18.6-1.4-17.1, 14.4

10 University of Pennsylvania School of Medicine Infections cumulative through cycle 6 Outcome BufferGel (n=621) Gynol II (N=300) P- value Symptomatic urinary tract infection 9 (%)14 (%)0.03 All urinary tract infections 16 (%)18 (%)0.30 Bacterial vaginosis (based on Nugents score) 27 (%) 0.94 Symptomatic yeast vaginitis 6 (%)8 (%)0.43

11 University of Pennsylvania School of Medicine Colposcopic Lesions BufferGel (n=76) Gynol II (N=35) P- value Baseline 42 (%)40 (%)0.84 Cycle 1 36 (%)47 (%)0.19 Cycle 3 29 (%)37 (%)0.39 Cycle 6 29 (%) 0.97 Average # of lesions/woman at follow-up 0.73 1.07 0.2

12 University of Pennsylvania School of Medicine Side Effects Event BufferGel (n=528) Gynol II (N=270) Irritation, any severity 35 (%)34 (%) Irritation, moderate or greater severity 9 (%)11 (%) Partner irritation 12 (%)10 (%) Vaginal pain 6 (%) Vaginal discharge 6 (%)4 (%) Intermenstrual bleeding 15 (%)17 (%) Irregular menstruation 14 (%)13 (%) Product discontinued because of AE 3.2 (%)3.7 (%)

13 University of Pennsylvania School of Medicine Acceptability at Cycle 6 BufferGel (n=528) Gynol II (N=270) P- value Overall impression of method (%) 0.66 Liked strongly 24 Liked somewhat 4448 Neutral 1614 Disliked somewhat 1312 Disliked strongly 42 Definitely or probably use product if available (%) 68700.56 Pref relative to condoms (%) 5457 0.50

14 University of Pennsylvania School of Medicine 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

15 University of Pennsylvania School of Medicine 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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