Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): a dose ranging, phase I study

John O'Loughlin, Iona Y. Millwood, Helen M. McDonald, Clare F. Price, John Kaldor, John M Kaldor, Jeremy Ra Paull, Jeremy R A Paull
Sexually transmitted diseases · 2010 · vol. 37(2) , pp. 100–104 · doi:10.1097/olq.0b013e3181bc0aac · PMID:19823111 · W2058062806
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This phase I trial evaluated the safety and pharmacokinetics of SPL7013 gel in healthy women, finding it safe and well-tolerated with no systemic absorption.

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This phase I study evaluated the safety, tolerability, and pharmacokinetics of escalating doses of SPL7013 Gel in thirty-seven healthy women over seven days. The randomized, double-blind trial found that vaginal application resulted in mild adverse events such as abdominal discomfort, with no systemic absorption or significant changes to vaginal flora that led to bacterial vaginosis. Researchers concluded that the gel was safe and well-tolerated at concentrations ranging from 0.5% to 3%, showing no evidence of systemic toxicity. The paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

OBJECTIVES: To evaluate safety, tolerability and systemic pharmacokinetics of escalating doses of SPL7013 Gel in healthy women. DESIGN: : Randomized, double-blind, placebo-controlled dose-escalation trial. METHODS: Thirty-seven healthy women were randomized to receive 3.5 g of 0.5% (N = 8), 1% (N = 8), or 3% (N = 9) SPL7013 Gel or placebo gel (N = 12), applied vaginally once daily for 7 consecutive days. Genital toxicity was determined by interview, physical examination, assessment of vaginal microflora and colposcopy. Systemic toxicity was determined by nongenital adverse events (AEs) and laboratory assessments. Plasma was collected for pharmacokinetic analysis. RESULTS: Genital AEs considered potentially product-related were all mild and reported by 5 (20%) women receiving SPL7013 Gel and 2 (17%) women receiving placebo gel. The most common were abdominal pain or discomfort, with no reports of vaginal burning or malodour, or genital-tract pain. There were no clinically significant colposcopic findings, including of genital inflammation or epithelial disruption. Lower concentrations of normal lactobacillary flora occurred during SPL7013 Gel and placebo gel use, with a decrease in anaerobes in the SPL7013 Gel groups. There were no reported cases of bacterial vaginosis, and lactobacilli returned to predose levels in most women after treatment. All nongenital AEs were of mild or moderate severity, expect for a severe tension headache in a woman receiving placebo. There was no absorption of SPL7013 into the systemic circulation. CONCLUSIONS: SPL7013 Gel applied vaginally once daily for 7 days at concentrations of 0.5% to 3% was safe and well tolerated in healthy, sexually abstinent women, with no evidence of systemic toxicity or absorption.
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Objectives

To evaluate safety, tolerability and systemic pharmacokinetics of escalating doses of SPL7013 Gel in healthy women. Design: Randomized, double-blind, placebo-controlled dose-escalation trial.

Methods

Thirty-seven healthy women were randomized to receive 3.5 g of 0.5% (N = 8), 1% (N = 8), or 3% (N = 9) SPL7013 Gel or placebo gel (N = 12), applied vaginally once daily for 7 consecutive days. Genital toxicity was determined by interview, physical examination, assessment of vaginal microflora and colposcopy. Systemic toxicity was determined by nongenital adverse events (AEs) and laboratory assessments. Plasma was collected for pharmacokinetic analysis.

Results

Genital AEs considered potentially product-related were all mild and reported by 5 (20%) women receiving SPL7013 Gel and 2 (17%) women receiving placebo gel. The most common were abdominal pain or discomfort, with no reports of vaginal burning or malodour, or genital-tract pain. There were no clinically significant colposcopic findings, including of genital inflammation or epithelial disruption. Lower concentrations of normal lactobacillary flora occurred during SPL7013 Gel and placebo gel use, with a decrease in anaerobes in the SPL7013 Gel groups. There were no reported cases of bacterial vaginosis, and lactobacilli returned to predose levels in most women after treatment. All nongenital AEs were of mild or moderate severity, expect for a severe tension headache in a woman receiving placebo. There was no absorption of SPL7013 into the systemic circulation.

Conclusions

SPL7013 Gel applied vaginally once daily for 7 days at concentrations of 0.5% to 3% was safe and well tolerated in healthy, sexually abstinent women, with no evidence of systemic toxicity or absorption.

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MeSH descriptors

Anti-Infective Agents Anti-Infective Agents Anti-Infective Agents Anti-Infective Agents Herpes Genitalis HIV Infections Polylysine Polylysine Polylysine Polylysine Vagina Vaginal Creams, Foams, and Jellies Vaginal Creams, Foams, and Jellies Vaginal Creams, Foams, and Jellies Vaginal Creams, Foams, and Jellies Administration, Intravaginal Adolescent Adult Colposcopy Dendrimers

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