{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T21:11:17Z","timestamp":1774559477322,"version":"3.50.1"},"reference-count":127,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2020,5,29]],"date-time":"2020-05-29T00:00:00Z","timestamp":1590710400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R44 HD092206-01"],"award-info":[{"award-number":["R44 HD092206-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R43\/44 AI084225"],"award-info":[{"award-number":["R43\/44 AI084225"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R42 AI069659"],"award-info":[{"award-number":["R42 AI069659"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,8,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Current modern contraceptives rely heavily on the use of hormones. These birth control drug products, including pills, patches, injections, and IUDS, have been extremely beneficial to millions of women and their families over the past 50\u00a0years. But a surprisingly high number of women abandon such modern methods, many because they cannot tolerate the side effects and others because they have medical issues for which hormonal methods are contraindicated. In addition, modern hormonal methods are simply not available to many women. The extent of this problem is steadily becoming more apparent.<\/jats:p>\n               <jats:p>We present the case for developing simple nonhormonal vaginal products that women can use when needed, ideal products that are multipurpose and offer both contraception and sexually transmitted disease protection. Gel-based vaginal products are particularly well suited for this purpose. Gels are easy to use, highly acceptable to many women, and can be safely formulated to enhance natural vaginal defenses against infection. However, the development of a new chemical entity for this application faces significant technical and regulatory hurdles. These challenges and our solutions are described for polyphenylene carboxymethylene (PPCM), a novel topical drug in a vaginal gel nearing human clinical trials. We have advanced PPCM from benchtop to IND-enabling studies and provide a brief description of the complex development process. We also describe a simple lab assay which can be used as a biomarker for contraceptive activity to enable pharmacodynamic studies in vaginal contraceptive development, both preclinically and in early human clinical trials.<\/jats:p>","DOI":"10.1093\/biolre\/ioaa087","type":"journal-article","created":{"date-parts":[[2020,5,29]],"date-time":"2020-05-29T10:56:13Z","timestamp":1590749773000},"page":"299-309","source":"Crossref","is-referenced-by-count":12,"title":["Development of multipurpose technologies products for pregnancy and STI prevention: update on polyphenylene carboxymethylene MPT gel development\u2020"],"prefix":"10.1093","volume":"103","author":[{"given":"Mary","family":"Weitzel","sequence":"first","affiliation":[{"name":"Yaso Therapeutics Inc, Scottsdale, AZ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara Best","family":"North","sequence":"additional","affiliation":[{"name":"Yaso Therapeutics Inc, Scottsdale, AZ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald","family":"Waller","sequence":"additional","affiliation":[{"name":"Yaso Therapeutics Inc, Scottsdale, AZ, USA"},{"name":"College of Pharmacy, University of Illinois, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,5,29]]},"reference":[{"key":"2020080407010777000_ref1","doi-asserted-by":"crossref","first-page":"843","DOI":"10.1056\/NEJMsa1506575","article-title":"Declines in unintended pregnancy in the United States, 2008\u20132011","volume":"374","author":"Finer","year":"2016","journal-title":"N Engl J Med"},{"key":"2020080407010777000_ref2","volume-title":"Unmet Need for Contraception in Developing Countries: Examining Women\u2019s Reasons for Not Using a Method (Report)","author":"Sedgh","year":"2016"},{"key":"2020080407010777000_ref3","volume-title":"Key Statistics from the National Survey of Family Growth\u2014C Listing","author":"CDC"},{"key":"2020080407010777000_ref4","volume-title":"Contraception discontinuations: Reasons, challenges, and solutions. 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A novel study design incorporating semen biomarkers","volume":"107140","author":"Gallo","year":"2011","journal-title":"Infect Dis Obstet Gyn"},{"key":"2020080407010777000_ref11","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1016\/j.contraception.2017.09.010","article-title":"Women's perceptions and treatment patterns related to contraception: Results of a survey of US women","volume":"97","author":"Nelson","year":"2018","journal-title":"Contraception"},{"key":"2020080407010777000_ref12","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1016\/j.contraception.2019.09.006","article-title":"Reasons for discontinuation of contraception among women with a current unintended pregnancy in 36 low and middle-income countries","volume":"101","author":"Bellizzi","year":"2020","journal-title":"Contraception"},{"key":"2020080407010777000_ref13","first-page":"14","article-title":"Contraception is not abortion: The strategic campaign of antiabortion groups to persuade the public otherwise","volume":"17","author":"Dreweke","year":"2014","journal-title":"Guttmacher Policy Review"},{"key":"2020080407010777000_ref14","volume-title":"Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications, Public Meeting","author":"FDA Center for Drug Evaluation and Research","year":"2015"},{"key":"2020080407010777000_ref15","doi-asserted-by":"crossref","first-page":"2228","DOI":"10.1056\/NEJMoa1700732","article-title":"Contemporary hormonal contraception and the risk of breast cancer","volume":"377","author":"March","year":"2017","journal-title":"N Engl J Med"},{"key":"2020080407010777000_ref16","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1016\/j.contraception.2017.10.003","article-title":"Contraceptive method use in the United States: Trends and characteristics between 2008, 2012 and 2014","volume":"97","author":"Kavanaugh","year":"2017","journal-title":"Contraception"},{"key":"2020080407010777000_ref17","first-page":"203","article-title":"Use of modern contraception increases when more methods become available: Analysis of evidence from 1982\u20132009","volume":"1","author":"Ross","year":"2013","journal-title":"Glob Health: Sci Pract"},{"key":"2020080407010777000_ref18","volume-title":"Levels, Trends, and Reasons for Contraceptive Discontinuation. 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