Noncomparative Contraceptive Efficacy of Cellulose Sulfate Gel

Mauck, Christine; Freziers, Ron G.; Walsh, Terri; Peacock, Karen; Schwartz, Jill L.; Callahan, Marianne M.

doi:10.1097/aog.0b013e3181644598

Cited by 24 publications

(14 citation statements)

References 16 publications

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“…1 Several microbicide candidates looked promising during preclinical evaluation but failed in efficacy trials: nonoxynol-9 (N-9), [2][3][4][5][6][7] Carraguard, 8 BufferGel, 9 PRO 2000, 10 and cellulose sulfate (CS). [11][12][13][14][15][16][17][18][19] CS did not prevent, and, when frequently used, may have increased the risk of HIV acquisition. 20,21 N-9, also when used frequently, raised the risk of HIV infection.…”

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confidence: 99%

Toward Early Safety Alert Endpoints: Exploring Biomarkers Suggestive of Microbicide Failure

Mauck

Lai

Weiner

et al. 2013

AIDS Research and Human Retroviruses

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TitleToward early safety alert endpoints: exploring biomarkers suggestive of microbicide failure. Several microbicides, including nonoxynol-9 (N-9) and cellulose sulfate (CS), looked promising during early trials but failed in efficacy trials. We aimed to identify Phase I mucosal safety endpoints that might explain that failure. In a blinded, randomized, parallel trial, 60 healthy premenopausal sexually abstinent women applied Universal HEC placebo, 6% CS or 4% N-9 gel twice daily for 13½ days. Endpoints included immune biomarkers in cervicovaginal lavage (CVL) and endocervical cytobrushes, inflammatory infiltrates in vaginal biopsies, epithelial integrity by naked eye, colposcopy, and histology, CVL anti-HIV activity, vaginal microflora, pH, and adverse events. Twenty women enrolled per group. Soluble/cellular markers were similar with CS and placebo, except secretory leukocyte protease inhibitor (SLPI) levels decreased in CVL, and CD3 + and CD45 + cells increased in biopsies after CS use. Increases in interleukin (IL)-8, IL-1, IL-1RA, and myeloperoxidase (MPO) and decreases in SLPI were significant with N-9. CVL anti-HIV activity was significantly higher during CS use compared to N-9 or placebo. CS users tended to have a higher prevalence of intermediate Nugent score, Escherichia coli, and Enterococcus and fewer gram-negative rods. Most Nugent scores diagnostic for bacterial vaginosis were in N-9 users. All cases of histological inflammation or deep epithelial disruption occurred in N-9 users. While the surfactant N-9 showed obvious biochemical and histological signs of inflammation, more subtle changes, including depression of SLPI, tissue influx of CD45 + and CD3 + cells, and subclinical microflora shifts were associated with CS use and may help to explain the clinical failure of nonsurfactant microbicides.

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confidence: 99%

Toward Early Safety Alert Endpoints: Exploring Biomarkers Suggestive of Microbicide Failure

Mauck

Lai

Weiner

et al. 2013

AIDS Research and Human Retroviruses

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“…Although no longer in clinical development as microbicides, CS, and PSS have successfully completed Phase 1 safety trials [13][14][15]. CS has successfully completed Phase 3 clinical trials as a contraceptive [16], suggesting its future clinical use in this regard. Results from the present study lend supporting evidence that CS is noncytotoxic.…”

Section: Discussionmentioning

confidence: 96%

Differential Sensitivity of Lactobacillus spp. to Inhibition by Candidate Topical Microbicides

Anderson

Aroutcheva

Feathergill

et al. 2009

Probiotics & Antimicro. Prot.

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Preclinical evaluation of vaginal microbicides includes screening against lactobacilli. However, there is no consensus regarding the species to be tested. This study was carried out to determine if results with one species would apply to other species, and to evaluate the utility of turbidometry as a screening tool. One current (PPCM; previously designated sulfuric acid-modified mandelic acid, SAMMA) and two former (cellulose sulfate, CS; and polystyrene sulfonate, PSS) candidate microbicides were evaluated. Bacterial growth was measured turbidometrically and by direct cell count. No microbicide affected Lact. gasseri, measured by either method. Apparent inhibition of Lact. jensenii by CS, PSS, and PPCM, and of Lact. crispatus by CS, occurred with turbidometric measurement. This was not substantiated with direct cell count. PSS and PPCM inhibited Lact. crispatus and Lact. acidophilus with both methods. These findings agree with results from vaginal isolates, which included Lact. gasseri, jensenii, acidophillus, crispatus, rhamnosis, casei, and paracasei. We conclude that sensitivities of similar lactobacilli to at least three microbicides are different. A single species is inadequate for screening vaginal products. Turbidometric evaluation is a sensitive, but not specific, screening method. We recommend that this method be used to screen candidate microbicides against several species of prevalent Lactobacillus species as an initial measure of microbicide safety evaluation.

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“…The 6-month pregnancy rates of about 12% for each product in the MITT population are consistent with rates seen in studies of nonoxynol-9. (16, 17, 18). Perfect-use pregnancy rates were about 5% with both products in our study.…”

Section: Discussionmentioning

confidence: 99%

Contraceptive Efficacy, Acceptability, and Safety of C31G and Nonoxynol-9 Spermicidal Gels

Burke

Barnhart

Jensen

et al. 2010

Obstetrics &Amp; Gynecology

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Objective To compare contraceptive efficacy, safety, and acceptability of C31G and nonoxynol-9 spermicidal gels. Methods We conducted a multicenter, randomized, double-masked, controlled trial to assess whether a gel containing the spermicide C31G was non-inferior to a commercially available product containing nonoxynol-9. Participants were healthy, sexually active females ages 18–40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. Sample size was calculated at a 2.5% significance level using a one-sided test, based on assumed 6-month pregnancy probability of 15% in the Conceptrol group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. Results Nine-hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized subjects with at least one episode of coitus (modified intent-to-treat group), six-month pregnancy probabilities were 12.0% (95% confidence interval (CI) 9.3–14.7%) and 12.0% (95%CI 8.7–15.3%) for C31G and nonoxynol-9 respectively. Twelve-month pregnancy probabilities were 13.8% (95%CI 7.6–20%) for C31G and 19.8% (95%CI 10.9–28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product, and neither occurred the C31G group. Three-fourths of users in either group reported that they liked their assigned study product. Approximately 40% of subjects discontinued prematurely for reasons other than pregnancy, with 11% lost to follow-up. Conclusion C31G demonstrated noninferior contraceptive efficacy compared to nonoxynol-9. Both products were safe and acceptable. C31G may provide another marketable option for women seeking spermicidal contraception.

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Noncomparative Contraceptive Efficacy of Cellulose Sulfate Gel

Abstract: Cellulose sulfate vaginal gel yields pregnancy rates comparable to nonoxynol-9 and few adverse events among couples at low risk for sexually transmitted diseases.

Cited by 24 publications

References 16 publications

Toward Early Safety Alert Endpoints: Exploring Biomarkers Suggestive of Microbicide Failure

Toward Early Safety Alert Endpoints: Exploring Biomarkers Suggestive of Microbicide Failure

Differential Sensitivity of Lactobacillus spp. to Inhibition by Candidate Topical Microbicides

Contraceptive Efficacy, Acceptability, and Safety of C31G and Nonoxynol-9 Spermicidal Gels

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