Quantitation of vaginally administered nonoxynol-9 in premenopausal women

Patricia Barditch-Crovo; Frank Witter; Fayez Hamzeh; Jason McPherson; Pamela Stratton; Nancy J. Alexander; Carol Braun Trapnell

doi:10.1016/S0010-7824(97)00003-6

Quantitation of vaginally administered nonoxynol-9 in premenopausal women

Patricia Barditch-Crovo, Frank Witter, Fayez Hamzeh, Jason McPherson, Pamela Stratton, Nancy J. Alexander, Carol Braun Trapnell

School of Medicine

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

A feasibility study was performed in 11 healthy nonpregnant premenopausal women to determine a method for collection and recovery of vaginally administered nonoxynol-9. We also determined if nonoxynol-9 could be quantitated in vaginal lavage fluid obtained 2 h after instillation of a standard precoital dose of a foam formulation of nonoxynol-9. Samples were analyzed in batch using a validated normal phase high-performance liquid chromatography (HPLC) method. Two hours after instillation of one dose of Delfen® Contraceptive Foam (100 mg), the quantity of nonoxynol-9 collected ranged from 10.8 to 67.8 mg (mean: 35.4 mg). This corresponds to a recovery of 11-70% of the administered dose. Quantitation of vaginally administered nonoxynol-9 is both practical and feasible. These data represent a critical first step in the evaluation of the safety and effectiveness of nonoxynol-9- containing products in the prevention of sexually transmitted diseases.

Original language	English (US)
Pages (from-to)	261-263
Number of pages	3
Journal	Contraception
Volume	55
Issue number	4
DOIs	https://doi.org/10.1016/S0010-7824(97)00003-6
State	Published - Apr 1997

Keywords

HIV prevention
Nonoxynol-9
STD prevention
Spermicide

ASJC Scopus subject areas

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/S0010-7824(97)00003-6

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title = "Quantitation of vaginally administered nonoxynol-9 in premenopausal women",

abstract = "A feasibility study was performed in 11 healthy nonpregnant premenopausal women to determine a method for collection and recovery of vaginally administered nonoxynol-9. We also determined if nonoxynol-9 could be quantitated in vaginal lavage fluid obtained 2 h after instillation of a standard precoital dose of a foam formulation of nonoxynol-9. Samples were analyzed in batch using a validated normal phase high-performance liquid chromatography (HPLC) method. Two hours after instillation of one dose of Delfen{\textregistered} Contraceptive Foam (100 mg), the quantity of nonoxynol-9 collected ranged from 10.8 to 67.8 mg (mean: 35.4 mg). This corresponds to a recovery of 11-70% of the administered dose. Quantitation of vaginally administered nonoxynol-9 is both practical and feasible. These data represent a critical first step in the evaluation of the safety and effectiveness of nonoxynol-9- containing products in the prevention of sexually transmitted diseases.",

keywords = "HIV prevention, Nonoxynol-9, STD prevention, Spermicide",

author = "Patricia Barditch-Crovo and Frank Witter and Fayez Hamzeh and Jason McPherson and Pamela Stratton and Alexander, {Nancy J.} and Trapnell, {Carol Braun}",

note = "Funding Information: This study was supported in part by the Food and Drug Administration, Center for Drug Evaluation and Research, Contract #223-93-3011, and the Office of Women{\textquoteright}s Health, FDA. Additional support for this study was furnished by the NIH-NCRR, OPD-GCRC Grant RR00722. The authors gratefully acknowledge Rachel Behr-man, M.D., Debra Birnkrant, M.D., Sheryl Lard, Ph.D., and Lisa Rarick, M.D. for their assistance in the design of the clinical study, and Laura ROCCO, M.S., for her assistance with the manuscript. Copyright: Copyright 2007 Elsevier B.V., All rights reserved.",

year = "1997",

month = apr,

doi = "10.1016/S0010-7824(97)00003-6",

language = "English (US)",

volume = "55",

pages = "261--263",

journal = "Contraception",

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T1 - Quantitation of vaginally administered nonoxynol-9 in premenopausal women

AU - Barditch-Crovo, Patricia

AU - Witter, Frank

AU - Hamzeh, Fayez

AU - McPherson, Jason

AU - Stratton, Pamela

AU - Alexander, Nancy J.

AU - Trapnell, Carol Braun

N1 - Funding Information: This study was supported in part by the Food and Drug Administration, Center for Drug Evaluation and Research, Contract #223-93-3011, and the Office of Women’s Health, FDA. Additional support for this study was furnished by the NIH-NCRR, OPD-GCRC Grant RR00722. The authors gratefully acknowledge Rachel Behr-man, M.D., Debra Birnkrant, M.D., Sheryl Lard, Ph.D., and Lisa Rarick, M.D. for their assistance in the design of the clinical study, and Laura ROCCO, M.S., for her assistance with the manuscript. Copyright: Copyright 2007 Elsevier B.V., All rights reserved.

PY - 1997/4

Y1 - 1997/4

N2 - A feasibility study was performed in 11 healthy nonpregnant premenopausal women to determine a method for collection and recovery of vaginally administered nonoxynol-9. We also determined if nonoxynol-9 could be quantitated in vaginal lavage fluid obtained 2 h after instillation of a standard precoital dose of a foam formulation of nonoxynol-9. Samples were analyzed in batch using a validated normal phase high-performance liquid chromatography (HPLC) method. Two hours after instillation of one dose of Delfen® Contraceptive Foam (100 mg), the quantity of nonoxynol-9 collected ranged from 10.8 to 67.8 mg (mean: 35.4 mg). This corresponds to a recovery of 11-70% of the administered dose. Quantitation of vaginally administered nonoxynol-9 is both practical and feasible. These data represent a critical first step in the evaluation of the safety and effectiveness of nonoxynol-9- containing products in the prevention of sexually transmitted diseases.

AB - A feasibility study was performed in 11 healthy nonpregnant premenopausal women to determine a method for collection and recovery of vaginally administered nonoxynol-9. We also determined if nonoxynol-9 could be quantitated in vaginal lavage fluid obtained 2 h after instillation of a standard precoital dose of a foam formulation of nonoxynol-9. Samples were analyzed in batch using a validated normal phase high-performance liquid chromatography (HPLC) method. Two hours after instillation of one dose of Delfen® Contraceptive Foam (100 mg), the quantity of nonoxynol-9 collected ranged from 10.8 to 67.8 mg (mean: 35.4 mg). This corresponds to a recovery of 11-70% of the administered dose. Quantitation of vaginally administered nonoxynol-9 is both practical and feasible. These data represent a critical first step in the evaluation of the safety and effectiveness of nonoxynol-9- containing products in the prevention of sexually transmitted diseases.

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KW - Nonoxynol-9

KW - STD prevention

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ER -

Quantitation of vaginally administered nonoxynol-9 in premenopausal women

Abstract

Keywords

ASJC Scopus subject areas

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