EXECUTIVE SUMMARY
What new methods can clinicians look to add to their arsenal of family planning options in the upcoming years? Several possible options are moving through the research pipeline.
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A 19 mg total dose levonorgestrel IUD that releases approximately 13 mcg/24 hours during the first year is under review at the Food and Drug Administration.
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Another intrauterine device in research is the VeraCept copper contraceptive IUD. A low dose of copper is loaded on the device’s biologically inert, spring-shaped, nitinol frame with tailstrings, with the copper concentrated near the tubal ostia and internal cervical os.
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Scientists Are Studying Use Of Polidocanol Foam, Approved As A Treatment For Varicose Veins, As A Nonsurgical Permanent Contraception Option.
What new methods can clinicians look to add to their arsenal of family planning options in the upcoming years? With the recent upsurge in interest in long-acting reversible contraceptives (LARCs), it’s no surprise that several possible LARC options are moving through the research pipeline.
In the realm of hormonal intrauterine devices (IUDs), a 19 mg total dose levonorgestrel IUD that releases approximately 13 mcg/24 hours during the first year is under review at the Food and Drug Administration (FDA), says Anita Nelson, MD, professor emeritus in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles.1 In a study of the efficacy and safety of two levonorgestrel intrauterine contraceptive systems (one with 13.5 mg and the other with 19 mg), over the three-year study period, 0.33 pregnancies per 100 women-years (95% confidence interval [CI], 0.16-0.60) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years (95% CI, 0.15-0.57) with the 19.5 mg intrauterine contraceptive system.2
Another intrauterine device in research is the VeraCept copper contraceptive IUD, says Nelson. A low dose of copper is loaded on the device’s biologically inert, spring-shaped, nitinol frame with tailstrings, with the copper concentrated near the tubal ostia and internal cervical os, Nelson states. Early research on the device’s efficacy, cramping, bleeding, expulsion, performed in the Dominican Republic, was presented at the 2015 American College of Obstetricians and Gynecologists annual meeting.3 ContraMed of Campbell, CA, developer of the device, announced the first enrollments in its U.S. Phase 2 clinical study of the device in July 2015. A total of 10 centers are participating in a study designed to evaluate the safety and effectiveness of VeraCept in a study population of parous and nulliparous women seeking long-acting, reversible contraception.
How about new options for women who are considering permanent contraception? In a new analysis of U.S. women using contraception, female sterilization was the second most-used option by current contraceptors. About one-quarter (25.1%, or 9.4 million women) named it as their current method of birth control.4
Jeffrey Jensen, MD, MPH, and his team at Oregon Health & Science University in Portland are looking at a safe, effective, and accessible nonsurgical permanent contraception for women around the world using polidocanol foam, which has been approved by the FDA as a treatment for varicose veins. Jensen is the Leon Speroff professor and vice chair of the research department of obstetrics & gynecology at the school.
“Polidocanol foam [PF] is currently being tested as a method of nonsurgical permanent contraception for women using a nonhuman primate model,” says Jensen. “We have shown that a single transcervical treatment with 5% PF can block the intramural portion of the fallopian tube without adverse non-target effects and that the occlusion that develops appears to be permanent.”5
Although the team has completed a contraceptive study in baboons, it has not published these results, says Jensen. The scientists are evaluating modifications of polidocanol foam aimed at increasing safety and effectiveness while reducing the dose, he notes.
Polidocanol foam is one of several approaches to nonsurgical permanent contraception under investigation at the Oregon Permanent Contraception Research Center, says Jensen. The Center was established at the Oregon National Primate Research Center at Oregon Health and Science University in November 2014 through a grant from the Bill and Melinda Gates Foundation in Seattle. The long-term goal of the center is focused on the development of a highly effective, safe, low-cost, nonsurgical, and highly portable method of permanent contraception to meet the unmet needs of women who have completed desired family size and voluntarily seek permanent contraception. Center Scientific Director Ov Slayden, PhD, and his team at the Oregon National Primate Research Center are working with Jensen’s team to develop such options for women around the globe.
REFERENCES
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Nelson AL. A look into the future: Contraceptive options in the pipeline. Presented at the 2015 Contraceptive Technology Quest for Excellence conference. Atlanta; November 2015.
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Nelson A, Apter D, Hauck B, et al. Two low-dose levonorgestrel intrauterine contraceptive systems: A randomized controlled trial. Obstet Gynecol 2013; 122(6):1205-1213.
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Reeves M, Hathaway MJ, Oleaga JMC, et al. A randomized single-blinded trial of VeraCept, a novel low-dose copper intrauterine contraceptive compared to the Copper T380S intrauterine contraceptive. Presented at the 2015 Annual Meeting of the American College of Obstetrics and Gynecology. San Francisco; May 2015.
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Daniels K, Daugherty J, Jones J, et al. Current contraceptive use and variation by selected characteristics among women aged 15-44: United States, 2011-2013. Natl Health Stat Report 2015; 86:1-15.
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Jensen JT, Hanna C, Yao S, et al. Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons. Contraception 2015; 92(2):96-102.
