Product Brief: Caucus on New and Underused Reproductive Health Technologies- Progesterone-only vaginal ring
Publication date: 2011
PRODUC T BRIEF Caucus on New and Underused Reproductive Health Technologies Progesterone-only vaginal ring Description !e progesterone-only vaginal ring Progering® is used to extend the contraceptive e"ectiveness of lactation among breastfeeding women. Progesterone-only vaginal rings are inserted in the vagina for continuous use up to three months and replaced with a new ring if breastfeeding is continued and extended contraception is desired. Women can use these rings continuously for up to one year. Although not recommended, the ring may be removed for comfort during sexual intercourse for a period up to two hours. If the ring is removed for a longer period of time, an additional contraceptive method should be used for the following seven days. Upon weaning of the breastfeeding infant, progesterone rings should be replaced with a method that contains both a progestin and an estrogen if continued contraception is desired.1 !e progesterone ring functions by di"using a continuous #ow of progesterone through the vaginal walls—approximately 10 mg per day—which then enters the blood stream and regulates the woman’s fertility. Progesterone thickens the cervical mucus, inhibiting sperm penetration into the uterus, and prevents ovulation and building up of the endometrium. Progesterone-only vaginal rings have a noteworthy presence in today’s contraceptive method mix, especially as a contraceptive choice for breastfeeding women. Acceptability studies conducted with other contraceptive rings in Australia, Canada, Chile, the Dominican Republic, the United States, and 12 European countries have demonstrated that women generally like the vaginal ring for many reasons, including its e"ectiveness; its ease of use, including insertion and removal; the user control of these actions; and the lack of need to check it regularly.2 Efficacy Clinical trials have shown a high contraceptive e%cacy (over 98.5 percent) and a good safety pro&le. !ere have been some side e"ect reports of vaginal discharge, urinary discomfort, bleeding disturbances, and rare reproductive tract infections. Yet in a Chilean study, less than 5 percent of users experienced any one of these side e"ects.3 !e e"ectiveness of the progesterone ring during the recommended three months of use has been shown to be comparable to that of the intrauterine device. While progesterone-only rings are less e"ective overall than rings containing both a progestin and an estrogen, they are highly e"ective among breastfeeding women because breastfeeding itself provides some protection from pregnancy. Also, they may be more appropriate for breastfeeding women because they do not contain estrogen, which can reduce milk production. !e most common reason for discontinuation of progesterone- only rings is weaning, as mothers choose more e"ective contraception a'er they stop breastfeeding. Bleeding disturbances, a common side e"ect of all progesterone-only methods, is another frequent reason for discontinuation.3 Current programme/sector use !e product Progering® is sold commercially in Peru and Chile through gynaecologists. !ere is limited data on commercial sales in these two countries, but it does not currently have a great deal of market penetration. !e product will also be tested in clinical trials in India during 2011, in anticipation of its registration and commercialization in Asia once approved by the Drug Controller of India. Manufacturer/supplier Progering® is the brand name of one progesterone- only vaginal ring currently available in Latin America, manufactured by Laboratorios Andromaco SA in Chile. !e product is supplied by Laboratorios Andromaco. Registration status Progering® was registered in Chile and Peru in 1998 for use by breastfeeding women. It has also been approved and launched recently in 2010 in other countries in Latin America including Bolivia, Ecuador, Guatemala, and the Dominican Republic. !e Population Council, CONRAD, the private companies Silesia SA and Andromaco SA funded its development. C A U C U S O N N EW A N D U N D ER U S ED R EP R O D U C TI V E H EA LT H T EC H N O LO G IE S P R O D U C T B R IE F This brief was last updated January 2011. For more information on the Caucus on New and Underused RH Technologies, please visit our web page at http://www.rhsupplies.org/working-groups/caucus-on-newunderused-rh-technologies.html. This publication forms part of a series of technical briefs, written by members of the Caucus on New and Underused Reproductive Health Technologies, a thematic group established under the auspices of the Reproductive Health Technologies Coalition. The Caucus’ aim is to broaden the discussion within the Coalition of reproductive health technologies that are not well integrated into the public or commercial health sectors. Responsibility for the selection and contents of the product briefs rests solely with the Caucus and does not imply endorsement by the Coalition or its wider membership. For additional information, please contact firstname.lastname@example.org. Public-sector price agreements None. References 1 Nath A, Sitruk-Ware R. Progesterone vaginal ring for contraceptive use during lactation. Contraception 2010; 82: 428–434. 2 Upadhyay UD. New contraceptive choices. Population Reports, Series M, No. 19. Baltimore: !e Johns Hopkins Bloomberg School of Public Health, INFO Project; April 2005. Available at: www.infoforhealth.org/pr/m19/ 3 Massai R, Miranda P, Valdes P, et al. Preregistration study on the safety and contraceptive e%cacy of a progesterone-releasing vaginal ring in Chilean nursing women. Contraception. 1999;60(1):9–14.