A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis

Marcus Y Chen, Iona Y Millwood, Handan Wand, Mary Poynten, John Martin Kaldor, Steven Lodewyk Wesselingh, Clare F Price, Laura J Clark, Christopher Kit Fairley

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Abstract

Abstract Objectives: To determine the safety of the candidate vaginal microbicide SPL7013 gel (VivaGel) when applied to the penis. Methods: A randomized, double-blind, placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised) were randomized in a 2:1 ratio and treated with 3 SPL7013 gel (n = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination. Results: There were 10 genital adverse events (AEs) in 6 men (25 ) receiving SPL7013 gel and 5 genital AEs in 4 men (33 ) receiving the placebo that were possibly or probably related to the study product (difference of -8 , 95 confidence interval: -40 to 23 , P = 0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group were transient. Analysis of vital signs, nongenital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma. Conclusions: Three percent SPL7013 gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity. Copyright ? 2009 by Lippincott Williams Wilkins.
Original languageEnglish
Pages (from-to)375 - 380
Number of pages6
JournalJAIDS
Volume50
Issue number4
DOIs
Publication statusPublished - 2009

Cite this

Chen, Marcus Y ; Millwood, Iona Y ; Wand, Handan ; Poynten, Mary ; Kaldor, John Martin ; Wesselingh, Steven Lodewyk ; Price, Clare F ; Clark, Laura J ; Fairley, Christopher Kit. / A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis. In: JAIDS. 2009 ; Vol. 50, No. 4. pp. 375 - 380.
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abstract = "Abstract Objectives: To determine the safety of the candidate vaginal microbicide SPL7013 gel (VivaGel) when applied to the penis. Methods: A randomized, double-blind, placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised) were randomized in a 2:1 ratio and treated with 3 SPL7013 gel (n = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination. Results: There were 10 genital adverse events (AEs) in 6 men (25 ) receiving SPL7013 gel and 5 genital AEs in 4 men (33 ) receiving the placebo that were possibly or probably related to the study product (difference of -8 , 95 confidence interval: -40 to 23 , P = 0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group were transient. Analysis of vital signs, nongenital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma. Conclusions: Three percent SPL7013 gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity. Copyright ? 2009 by Lippincott Williams Wilkins.",
author = "Chen, {Marcus Y} and Millwood, {Iona Y} and Handan Wand and Mary Poynten and Kaldor, {John Martin} and Wesselingh, {Steven Lodewyk} and Price, {Clare F} and Clark, {Laura J} and Fairley, {Christopher Kit}",
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A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis. / Chen, Marcus Y; Millwood, Iona Y; Wand, Handan; Poynten, Mary; Kaldor, John Martin; Wesselingh, Steven Lodewyk; Price, Clare F; Clark, Laura J; Fairley, Christopher Kit.

In: JAIDS, Vol. 50, No. 4, 2009, p. 375 - 380.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis

AU - Chen, Marcus Y

AU - Millwood, Iona Y

AU - Wand, Handan

AU - Poynten, Mary

AU - Kaldor, John Martin

AU - Wesselingh, Steven Lodewyk

AU - Price, Clare F

AU - Clark, Laura J

AU - Fairley, Christopher Kit

PY - 2009

Y1 - 2009

N2 - Abstract Objectives: To determine the safety of the candidate vaginal microbicide SPL7013 gel (VivaGel) when applied to the penis. Methods: A randomized, double-blind, placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised) were randomized in a 2:1 ratio and treated with 3 SPL7013 gel (n = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination. Results: There were 10 genital adverse events (AEs) in 6 men (25 ) receiving SPL7013 gel and 5 genital AEs in 4 men (33 ) receiving the placebo that were possibly or probably related to the study product (difference of -8 , 95 confidence interval: -40 to 23 , P = 0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group were transient. Analysis of vital signs, nongenital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma. Conclusions: Three percent SPL7013 gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity. Copyright ? 2009 by Lippincott Williams Wilkins.

AB - Abstract Objectives: To determine the safety of the candidate vaginal microbicide SPL7013 gel (VivaGel) when applied to the penis. Methods: A randomized, double-blind, placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised) were randomized in a 2:1 ratio and treated with 3 SPL7013 gel (n = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination. Results: There were 10 genital adverse events (AEs) in 6 men (25 ) receiving SPL7013 gel and 5 genital AEs in 4 men (33 ) receiving the placebo that were possibly or probably related to the study product (difference of -8 , 95 confidence interval: -40 to 23 , P = 0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group were transient. Analysis of vital signs, nongenital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma. Conclusions: Three percent SPL7013 gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity. Copyright ? 2009 by Lippincott Williams Wilkins.

UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2680448/

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SP - 375

EP - 380

JO - JAIDS

JF - JAIDS

SN - 1525-4135

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