PRODUCT BRIEF Caucus on New and Underused Reproductive Health Technologies

Female

Description silicone-based lubricant. The Woman’s Condom is made of thin polyurethane film and is packaged The female condom (FC) is a condom made of a soft, un-lubricated. Each Woman’s Condom is supplied thin material that fits inside a woman’s . Like with a separate sachet of water-based lubricant to be the male condom, the female condom is a barrier applied at point of use. method, keeping the penis and sperm from contact In 2012, the United Nations (UN) Commission on with the cervix and vagina. Unlike the male condom, Life-Saving Commodities for Women and Children however, it also covers parts of the external female endorsed female as one of its 13 Life-Saving genitalia. The female condom offers protection against Commodities, catalyzing inter-organizational efforts both unintended and sexually transmitted to overcome several commodity-specific barriers infections (STIs), including HIV. currently inhibiting women in the developing world Current models on the market have a flexible ring, from benefiting from this product. sponge, or capsule containing foam shapes at the closed end of the condom, enabling insertion of the device and helping to keep the condom in place Safety, efficacy, and acceptability during sex. A ring or frame at the open end of the Data from the 2007 World Health Organization condom stays outside the vagina, lying flat across the (WHO) handbook indicates that genital area and ensuring that the condom stays in about 21 occur per 100 women using place, as well as protecting from external STIs. The female condoms over the first year. When female female condom can be inserted into the vagina prior condoms are used correctly with every act of sex, to *, is not dependent on a male about five pregnancies occur per 100 women over the , and can remain in place after ejaculation. It first year.1 Although earlier effectiveness studies of has no known side effects or risks and can be used by female condoms were undertaken with FC1® female women of all ages.** condom (no longer on the market), the WHO and the A number of female condom products are currently US Food and Drug Administration (USFDA) have available to consumers while others are still in determined that the FC2® is equivalent to the FC1®, development. The first generation female condom based on pre-clinical and clinical studies.2 Currently, (FC1®), manufactured by the Female Health Company FC2® female condom is used as a control in studies to (FHC), was a silicone-lubricated, polyurethane assess performance and acceptability of newer female sheath, which came on the market in 1992. It has condom models. For example, a randomized crossover now been replaced by a second-generation product, study published in 2012 assessed the functional the FC2®, identical in design and appearance to FC1® performance, safety, and acceptability of three but made of nitrile, synthetic latex, which has lower new FCs: the Woman’s Condom, Cupid™, and VA manufacturing costs. In addition to the FC2®, there w.o.w® (not currently on the market). The study was are other female condom models on the market, such conducted in China and South Africa and concluded as Cupid™, the Woman’s Condom, and Phoenurse®. that the three condoms are non-inferior and function The Cupid™ female condom is made of natural rubber as well as the FC2®.3 latex and comes lubricated with silicone, but can Female condoms are the only female-initiated also be used with water-based lubricants. Oil-based methods of HIV prevention that are safe and effective. lubricants cannot be used with natural rubber latex Studies from 40 countries show acceptability rates condoms. The Phoenurse® female condom is made ranging from 37 to 93 percent.4,5 of polyurethane and comes pre-lubricated with a

* The amount of time prior to sexual intercourse varies per female condom model; please check manufacturer specifications. ** Women who are allergic to latex are recommended to not use latex female condoms. CAUCUS ON NEW AND UNDERUSED REPRODUCTIVE HEALTH TECHNOLOGIES PRODUCT BRIEF UN agencies. Until now, Cupid™ the was distributed prequalified and approved for bulk procurement by The Cupid™ condomfemale has recently WHObeen ofsales 60million units of FC2®in2012. Theministries. Female Company Health reported Population Fund (UNFPA), and governmental health Development United (USAID),the Nations organizations such as USAgency the for International The FC2® is purchased for public-sector programs by of countries. these inseveral underway in 130countries, and public-sector programs are Since 1993,female condoms have distributed been Current program/sector use a European Community declaration of conformity. The document hasbe made to available to authorities on request. do have obligatory to certain take steps before product the CE canmarking: the bear must they complete a conformity assessment, up set a file,technical and sign **** The manufacturer of a product affixes theCE marking to it, assuring theproduct meets European EconomicArea regulations. However, the manufacturers on various procurement conditions, including volume and contractual stipulation. *** Pricing information on table inthis most is the based accurate information and/or estimates provided by manufacturer. the Prices may fluctuate depending condom were sold. reported that over 2.5million units of female the 2010and 2013,Cupid Between South Africa. Ltd. Kyrgyz Republic, Mozambique, Netherlands, the and through limited channels inBrazil, India, Indonesia, pre-lubricated Made of rubberlatex, Cupid™ female condom latex), pre-lubricated Made of nitrile (synthetic many other names) Femidon, Protectiv, Care, and known underthebrand name FC2® female condom (also PRODUCT silicone-based lubricantsilicone-based with pre-lubricated Made of polyurethane, Phoenurse® female condom water-based lubricant packagedNon-lubricated, with made of polyvinyl alcohol; dissolving insertion capsule made of polyurethane; andfoamPouch, ring, shapes China market) known asO’lavie™ for the Woman’s Condom (also

Company, China Medical Apparatus Shanghai Dahua Cupid Ltd., India Company Female Health MANUFACTURER Tianjin, China Tech. Co. Ltd, Medical Polyurethane Tianjin Condombao

6 REGULATORY STATUS CE marking USFDA approval effectiveness study needed for Undergoing contraceptive prequalification; Under WHO review for CE marking; initiated in2012 USFDA registration process WHO prequalified 2012; CE marking; USFDA approved 2009 WHO prequalified 2007, 2012; CE marking;*** products that are currently on market. the and registration status of five the condomfemale Included below is key information on manufacture the distribution and Manufacturers procurement agencies. procured and distributed in2012,by globally major female condoms worth US$28.2million were According to Reproductive the Health Interchange, available in2013. inSouth Africa channels since late 2011.It to become is expected market, available has been inlimited inChina Woman’s Condom, branded O’lavie™ for Chinese the products with limited distribution The inChina. The Woman’sCondom and Phoenurse® are newer DISTRIBUTION Sri Lanka Kenya, Mexico, and Brazil, China, in China sector distribution Limited private- South Africa Netherlands, and Mozambique, the Kyrgyz Republic, Indonesia, Brazil, India, countries Available in130 7 ESTIMATES*** PRICE apply discounts may 0.59/unit; volume may apply volume discounts million units, $0.87/unit at5 million units $0.45/unit at5 $0.55/unit 2 CAUCUS ON NEW AND UNDERUSED REPRODUCTIVE HEALTH TECHNOLOGIES PRODUCT BRIEF African BureauAfrican of Standards. The Woman’sCondom is (ANVISA), Indian Control Drug Authority, and South registered with Brazilian the Agency Regulatory with USFDA. Cupid™ female condom is currently has initiated female the condom registration process receiving WHO prequalification in2012, Cupid Ltd. currently pending registration infour countries. After approved, FC2®is the registered in30countries and is In addition to WHO being prequalified and USFDA environmental requirements. has met European Union consumer safety, and health, haveall that aCEmarking, the certifies which product The FC2®, Cupid™, Phoenurse®, and Woman’sCondom status Registration endorsement by theCoalition orits wider membership. For additional information, please contact health sectors. Responsibility for theselectionand contents of theproduct briefs rests solely with theCaucus and does not imply broaden thediscussion within theCoalition of reproductive health technologies that are not well integrated into thepublic orcommercial Technologies, athematic group established under theauspices of theReproductive Health Supplies Coalition. The Caucus’ aimis to This publication forms part of aseries of technical briefs, written by members of theCaucus onNewand Underused Reproductive Health http://www.rhsupplies.org/working-groups/caucus-on-newunderused-rh-technologies.html For more information ontheCaucus onNewand Underused RHTechnologies, please visit our web page at that sustainableexpected price reductions are feasible. to female condoms. on market Based analysis it is reductions areto achieve universal necessary access Globally, it is acknowledged price that further datethe of publication. this have not to sold public-sector been purchasers as of public Phoenurse® inChina. sector female condoms system. The Woman’sCondomsold the been to has Republic through UNFPA for public their distribution The Cupid™ condomsfemale havesold in been Kyrgyz training and education by FHC over next the sixyears. with amultiyear agreement to provide $14million in on prior the based goods year’s purchases, together on aggregatebased purchases and 5percent free and announced aprospective pricing arrangement FC2® female condom for world’s the poorest countries Female Health Company pledged to increase access to At 2012Family the Planning Summit inLondon, the Public-sector price agreements and China. underway. Phoenurse® is currently registered inBrazil registered and inChina registration is inSouth Africa 7. 6. 5. 4. 3. 2. 1. References www.myaccessrh.org/rhi-home. Accessed March 11,2013. Reproductive Health Interchange website. Available at: http:// femalehealth.com. The Female Company Health website. Available www.at: WHO. far, H,etal. The condom:female Cecil what we havethus learned Report Woman’s Condom (WC), FC2,VA w.o.w. and Cupid: Final Performance of New Female Condoms: An Evaluation of the Joanis C. cfm?num=P080002. Accessed February 13,2013. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma. EffectivenessData –FC2 FemaleCondom US Food and Administration. Drug Providers INFOProject.(CCP) ofSchool Public Health/Center for Communication Programs Reproductive Health and Research, Johns Hopkins Bloomberg World Health Organization (WHO) Department of AIDS and Behavior . Joanis Consulting: Kennesaw, 2012. Georgia; The FemaleCondom: A Review . Geneva and. Geneva Baltimore: WHO and 2007. CCP; A Randomized Controlled Trial of the Functional [email protected] Family Planning: AGlobal Handbook for . 1998;2(3):241–256. This brief was last updated May 2013 May updated waslast brief This Summary of Safety and . Geneva: WHO;. Geneva: 1997. . Available at: http:// . .

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