A Phase I Randomized Postcoital Testing and Safety Study of the Caya Diaphragm used with 3% Nonoxynol-9 gel, ContraGel, or No Gel
Abstract Objectives The Caya® Diaphragm is a newly approved single-size, non-latex diaphragm. Contragel® is a personal lubricant containing lactic acid approved in Europe and other countries for use with vaginal barrier devices. This study assessed the effectiveness in preventing sperm from penetrat...
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| Veröffentlicht in: | Contraception (Stoneham) 2017-08, Vol.96 (2), p.124-130 |
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| creator | Mauck, Christine K Brache, Vivian Kimble, Thomas Thurman, Andrea Cochon, Leila Littlefield, Sarah Linton, Kim Doncel, Gustavo F Schwartz, Jill L |
| description | Abstract Objectives The Caya® Diaphragm is a newly approved single-size, non-latex diaphragm. Contragel® is a personal lubricant containing lactic acid approved in Europe and other countries for use with vaginal barrier devices. This study assessed the effectiveness in preventing sperm from penetrating midcycle cervical mucus of Caya with Contragel, Caya with 3% nonoxynol-9 (N-9), and Caya alone. Study Design Phase I multi-center, single-blind, randomized, crossover, non-significant risk study at 2 sites: Eastern Virginia Medical School, Norfolk, VA, and Profamilia, Santo Domingo, Dominican Republic. Healthy, sexually active women 18–45 years old, not at risk for pregnancy due to tubal occlusion were eligible. Each participant was seen in 9 visits, completing a baseline cycle (without product use) followed by 3 test cycles (sequence determined by randomization), each consisting of a cervical mucus check visit and a postcoital test visit. To proceed to test cycles, the baseline postcoital test had to show adequate cervical mucus and>5 progressively motile sperm per high power field (PMS/HPF). Results All women had an average of |
| doi_str_mv | 10.1016/j.contraception.2017.05.016 |
| format | Article |
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Contragel® is a personal lubricant containing lactic acid approved in Europe and other countries for use with vaginal barrier devices. This study assessed the effectiveness in preventing sperm from penetrating midcycle cervical mucus of Caya with Contragel, Caya with 3% nonoxynol-9 (N-9), and Caya alone. Study Design Phase I multi-center, single-blind, randomized, crossover, non-significant risk study at 2 sites: Eastern Virginia Medical School, Norfolk, VA, and Profamilia, Santo Domingo, Dominican Republic. Healthy, sexually active women 18–45 years old, not at risk for pregnancy due to tubal occlusion were eligible. Each participant was seen in 9 visits, completing a baseline cycle (without product use) followed by 3 test cycles (sequence determined by randomization), each consisting of a cervical mucus check visit and a postcoital test visit. To proceed to test cycles, the baseline postcoital test had to show adequate cervical mucus and>5 progressively motile sperm per high power field (PMS/HPF). Results All women had an average of<5 PMS/HPF during the test cycle of each study arm, the primary endpoint. Caya with ContraGel and Caya with N-9 reduced the average number of PMS/HPF from 22.5 to zero. Caya alone reduced the average number of PMS/HPF from 22.5 to 0.4. There were 2 possibly product-related mild adverse events. Conclusion This study supports that Caya with ContraGel is safe and functions as well as Caya with N-9 in preventing progressively motile sperm from reaching midcycle cervical mucus. Implications A single-size diaphragm used with a personal lubricant gel containing lactic acid appears to be safe and to function as well as the same diaphragm used with N-9 in preventing progressively motile sperm from reaching midcycle cervical mucus.</description><identifier>ISSN: 0010-7824</identifier><identifier>EISSN: 1879-0518</identifier><identifier>DOI: 10.1016/j.contraception.2017.05.016</identifier><identifier>PMID: 28606382</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Caya ; Contraceptive Devices, Female - adverse effects ; ContraGel ; Diaphragm ; Female ; Humans ; Middle Aged ; Nonoxynol - adverse effects ; Nonoxynol-9 ; Obstetrics and Gynecology ; Postcoital test ; SILCS ; Single-Blind Method ; Spermatocidal Agents - adverse effects ; Young Adult</subject><ispartof>Contraception (Stoneham), 2017-08, Vol.96 (2), p.124-130</ispartof><rights>2017 Elsevier Inc.</rights><rights>Copyright © 2017 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c438t-4e9aa5f98d7e752cf8d1d945c84811bc5769482949507ebed8459022282348cd3</citedby><cites>FETCH-LOGICAL-c438t-4e9aa5f98d7e752cf8d1d945c84811bc5769482949507ebed8459022282348cd3</cites><orcidid>0000-0003-2621-4739 ; 0000-0002-5405-3496</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.contraception.2017.05.016$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28606382$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mauck, Christine K</creatorcontrib><creatorcontrib>Brache, Vivian</creatorcontrib><creatorcontrib>Kimble, Thomas</creatorcontrib><creatorcontrib>Thurman, Andrea</creatorcontrib><creatorcontrib>Cochon, Leila</creatorcontrib><creatorcontrib>Littlefield, Sarah</creatorcontrib><creatorcontrib>Linton, Kim</creatorcontrib><creatorcontrib>Doncel, Gustavo F</creatorcontrib><creatorcontrib>Schwartz, Jill L</creatorcontrib><title>A Phase I Randomized Postcoital Testing and Safety Study of the Caya Diaphragm used with 3% Nonoxynol-9 gel, ContraGel, or No Gel</title><title>Contraception (Stoneham)</title><addtitle>Contraception</addtitle><description>Abstract Objectives The Caya® Diaphragm is a newly approved single-size, non-latex diaphragm. Contragel® is a personal lubricant containing lactic acid approved in Europe and other countries for use with vaginal barrier devices. This study assessed the effectiveness in preventing sperm from penetrating midcycle cervical mucus of Caya with Contragel, Caya with 3% nonoxynol-9 (N-9), and Caya alone. Study Design Phase I multi-center, single-blind, randomized, crossover, non-significant risk study at 2 sites: Eastern Virginia Medical School, Norfolk, VA, and Profamilia, Santo Domingo, Dominican Republic. Healthy, sexually active women 18–45 years old, not at risk for pregnancy due to tubal occlusion were eligible. Each participant was seen in 9 visits, completing a baseline cycle (without product use) followed by 3 test cycles (sequence determined by randomization), each consisting of a cervical mucus check visit and a postcoital test visit. To proceed to test cycles, the baseline postcoital test had to show adequate cervical mucus and>5 progressively motile sperm per high power field (PMS/HPF). Results All women had an average of<5 PMS/HPF during the test cycle of each study arm, the primary endpoint. Caya with ContraGel and Caya with N-9 reduced the average number of PMS/HPF from 22.5 to zero. Caya alone reduced the average number of PMS/HPF from 22.5 to 0.4. There were 2 possibly product-related mild adverse events. Conclusion This study supports that Caya with ContraGel is safe and functions as well as Caya with N-9 in preventing progressively motile sperm from reaching midcycle cervical mucus. Implications A single-size diaphragm used with a personal lubricant gel containing lactic acid appears to be safe and to function as well as the same diaphragm used with N-9 in preventing progressively motile sperm from reaching midcycle cervical mucus.</description><subject>Adolescent</subject><subject>Caya</subject><subject>Contraceptive Devices, Female - adverse effects</subject><subject>ContraGel</subject><subject>Diaphragm</subject><subject>Female</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Nonoxynol - adverse effects</subject><subject>Nonoxynol-9</subject><subject>Obstetrics and Gynecology</subject><subject>Postcoital test</subject><subject>SILCS</subject><subject>Single-Blind Method</subject><subject>Spermatocidal Agents - adverse effects</subject><subject>Young Adult</subject><issn>0010-7824</issn><issn>1879-0518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUtGK1DAUDaK44-ovSEAEH2xN0naSIAjLuK4Liy7O-hwyye1MxrYZk1Stb_65qbMK-uRTLpxz7s095yL0hJKSErp8sS-NH1LQBg7J-aFkhPKSNGXG7qAFFVwWpKHiLloQQknBBatP0IMY94QQLht-H50wsSTLSrAF-nGGr3c6Ar7EH_Rgfe--g8XXPibjXdIdvoGY3LDFGcRr3UKa8DqNdsK-xWkHeKUnjV87fdgFve3xGLP8q0s7XD3F7_zgv02D7wqJt9A9x6tfH7-YSx8yjHP5EN1rdRfh0e17ij6-Ob9ZvS2u3l9crs6uClNXIhU1SK2bVgrLgTfMtMJSK-vGiFpQujENX8paMFnLhnDYgBV1IwljTLCqFsZWp-jZse8h-M9j3kr1LhroOj2AH6OikkhWZbdYpr48Uk3wMQZo1SG4XodJUaLmDNRe_ZWBmjNQpFEZy-rHt4PGTQ_2j_a36ZlwfiRAXveLg6CicTAYsC6AScp695-DXv3Tx3RucEZ3n2CCuPdjGLKjiqrIFFHr-Rzma6C8muV19RMn_7Mn</recordid><startdate>20170801</startdate><enddate>20170801</enddate><creator>Mauck, Christine K</creator><creator>Brache, Vivian</creator><creator>Kimble, Thomas</creator><creator>Thurman, Andrea</creator><creator>Cochon, Leila</creator><creator>Littlefield, Sarah</creator><creator>Linton, Kim</creator><creator>Doncel, Gustavo F</creator><creator>Schwartz, Jill L</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2621-4739</orcidid><orcidid>https://orcid.org/0000-0002-5405-3496</orcidid></search><sort><creationdate>20170801</creationdate><title>A Phase I Randomized Postcoital Testing and Safety Study of the Caya Diaphragm used with 3% Nonoxynol-9 gel, ContraGel, or No Gel</title><author>Mauck, Christine K ; Brache, Vivian ; Kimble, Thomas ; Thurman, Andrea ; Cochon, Leila ; Littlefield, Sarah ; Linton, Kim ; Doncel, Gustavo F ; Schwartz, Jill L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c438t-4e9aa5f98d7e752cf8d1d945c84811bc5769482949507ebed8459022282348cd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Caya</topic><topic>Contraceptive Devices, Female - adverse effects</topic><topic>ContraGel</topic><topic>Diaphragm</topic><topic>Female</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Nonoxynol - adverse effects</topic><topic>Nonoxynol-9</topic><topic>Obstetrics and Gynecology</topic><topic>Postcoital test</topic><topic>SILCS</topic><topic>Single-Blind Method</topic><topic>Spermatocidal Agents - adverse effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mauck, Christine K</creatorcontrib><creatorcontrib>Brache, Vivian</creatorcontrib><creatorcontrib>Kimble, Thomas</creatorcontrib><creatorcontrib>Thurman, Andrea</creatorcontrib><creatorcontrib>Cochon, Leila</creatorcontrib><creatorcontrib>Littlefield, Sarah</creatorcontrib><creatorcontrib>Linton, Kim</creatorcontrib><creatorcontrib>Doncel, Gustavo F</creatorcontrib><creatorcontrib>Schwartz, Jill L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Contraception (Stoneham)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mauck, Christine K</au><au>Brache, Vivian</au><au>Kimble, Thomas</au><au>Thurman, Andrea</au><au>Cochon, Leila</au><au>Littlefield, Sarah</au><au>Linton, Kim</au><au>Doncel, Gustavo F</au><au>Schwartz, Jill L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase I Randomized Postcoital Testing and Safety Study of the Caya Diaphragm used with 3% Nonoxynol-9 gel, ContraGel, or No Gel</atitle><jtitle>Contraception (Stoneham)</jtitle><addtitle>Contraception</addtitle><date>2017-08-01</date><risdate>2017</risdate><volume>96</volume><issue>2</issue><spage>124</spage><epage>130</epage><pages>124-130</pages><issn>0010-7824</issn><eissn>1879-0518</eissn><abstract>Abstract Objectives The Caya® Diaphragm is a newly approved single-size, non-latex diaphragm. Contragel® is a personal lubricant containing lactic acid approved in Europe and other countries for use with vaginal barrier devices. This study assessed the effectiveness in preventing sperm from penetrating midcycle cervical mucus of Caya with Contragel, Caya with 3% nonoxynol-9 (N-9), and Caya alone. Study Design Phase I multi-center, single-blind, randomized, crossover, non-significant risk study at 2 sites: Eastern Virginia Medical School, Norfolk, VA, and Profamilia, Santo Domingo, Dominican Republic. Healthy, sexually active women 18–45 years old, not at risk for pregnancy due to tubal occlusion were eligible. Each participant was seen in 9 visits, completing a baseline cycle (without product use) followed by 3 test cycles (sequence determined by randomization), each consisting of a cervical mucus check visit and a postcoital test visit. To proceed to test cycles, the baseline postcoital test had to show adequate cervical mucus and>5 progressively motile sperm per high power field (PMS/HPF). Results All women had an average of<5 PMS/HPF during the test cycle of each study arm, the primary endpoint. Caya with ContraGel and Caya with N-9 reduced the average number of PMS/HPF from 22.5 to zero. Caya alone reduced the average number of PMS/HPF from 22.5 to 0.4. There were 2 possibly product-related mild adverse events. Conclusion This study supports that Caya with ContraGel is safe and functions as well as Caya with N-9 in preventing progressively motile sperm from reaching midcycle cervical mucus. Implications A single-size diaphragm used with a personal lubricant gel containing lactic acid appears to be safe and to function as well as the same diaphragm used with N-9 in preventing progressively motile sperm from reaching midcycle cervical mucus.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28606382</pmid><doi>10.1016/j.contraception.2017.05.016</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-2621-4739</orcidid><orcidid>https://orcid.org/0000-0002-5405-3496</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0010-7824 |
| ispartof | Contraception (Stoneham), 2017-08, Vol.96 (2), p.124-130 |
| issn | 0010-7824 1879-0518 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Adolescent Caya Contraceptive Devices, Female - adverse effects ContraGel Diaphragm Female Humans Middle Aged Nonoxynol - adverse effects Nonoxynol-9 Obstetrics and Gynecology Postcoital test SILCS Single-Blind Method Spermatocidal Agents - adverse effects Young Adult |
| title | A Phase I Randomized Postcoital Testing and Safety Study of the Caya Diaphragm used with 3% Nonoxynol-9 gel, ContraGel, or No Gel |
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