Executive Summary
The need for new contraception options is clear. In the United States, about half of the some 3.4 million pregnancies each year are unintended.
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At current rates, more than half of all U.S. women will have faced an unintended pregnancy by age 45, and almost a third will have had an abortion by that age.
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The Food and Drug Administration is reviewing a New Drug Application for Levosert, a hormonal intrauterine contraceptive.
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Advanced research is looking at the efficacy, safety, and tolerability of Agile Therapeutics’ investigational once-weekly transdermal contraceptive patch, Twirla.
As Contraceptive Technology Update enters its 35th year, what new methods can clinicians look to add to their arsenal of family planning options?
The need for new contraception options is clear. In the United States, about half of the some 3.4 million pregnancies each year are unintended.1 At current rates, more than half of all U.S. women will have faced an unintended pregnancy by age 45, and almost a third will have had an abortion by that age.1
Increased use of long-acting reversible contraceptive methods (LARC methods), such as implants and intrauterine devices (IUDs), has the potential to lower unintended pregnancy rates, says Lisa Haddad, MD, MS, MPH, assistant professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. Haddad spoke on LARC methods at the recent Contraceptive Technology conference in Atlanta.2
"IUDs and the contraceptive implant are the best reversible methods for preventing unintended pregnancy, rapid repeat pregnancy, and abortion in young women," says Haddad, who points to recommendations from the American College of Obstetricians and Gynecologists on the subject.3 "LARC methods should be first-line recommendations for all women and adolescents."
Clinicians soon might see an additional levonorgestrel IUD: The Food and Drug Administration (FDA) is reviewing a New Drug Application for Levosert, a hormonal intrauterine contraceptive. The device is under development by Medicines360, a San Francisco-based non-profit women’s health pharmaceutical company, and Actavis plc, a global specialty pharmaceutical company. The two companies entered into a partnership in 2013 to make the Levosert commercially available in the United States and at an affordable price for U.S. family planning clinics. The device is a T-shaped polyethylene frame with a steroid reservoir around its vertical stem. The reservoir contains 52 mg levonorgestrel, which provides a daily release rate of 20 mcg. (To read more about the device, see the CTU article, "New intrauterine device now is in research," September 2013, p. 104.)
While not yet in U.S. development, a spherical IUD developed by OCON Medical of Modiin, Israel, won European marketing approval in 2014. Due to its form and deployment process, the SCu300A copper uterine device is expected to ease insertion and reduce perforation, malposition, and expulsion rates, and it also might reduce dysmenorrhea and menorrhagia.4 The company has begun a North American clinical trial of a second device, which is designed with a larger copper surface area than the original model.
New patch in sight?
Advanced research is looking at a new contraceptive patch for women. Agile Therapeutics, a Princeton, NJ-based women’s health specialty pharmaceutical company, initiated a Phase 3 study in September 2014 to assess the efficacy, safety, and tolerability of Agile’s investigational once-weekly transdermal contraceptive patch, Twirla (AG200-15).
The Phase 3 study, a single-arm, open-label, multicenter investigation, will enroll approximately 2,100 women who will use the patch for up to one year to determine its contraceptive effectiveness. As of November 2014, approximately 50 of the planned 70 clinical sites had been activated, states company spokesperson Mary Coleman. The company anticipates completing the trial at the end of the first quarter of 2016, she says.
The investigational patch is designed to deliver 120 mg/day levonorgestrel with 25 mg/day ethinyl estradiol. The patch is under FDA review. (To read more about the patch, see the CTU article "Options being eyed for transdermal contraception," March 2014, p. 31.)
In March 2014, Bayer AG of Leverkusen, Germany, successfully concluded the registration procedure in the European Union for a new transparent low-dose contraceptive patch, FC-Patch Low. The patch is transparent and contains 0.55 mg ethinyl estradiol and 2.1 mg gestodene. Results of a recently published study indicate the patch is effective in preventing pregnancy.5 Menstrual bleeding pattern was favorable and within the ranges expected of a healthy female population, findings suggest.5 While gestodene has been in use as a contraceptive agent in European countries for more than 20 years, no U.S.-approved birth control method contains it.
Researchers also are looking at a new progestin-only pill for women who cannot take estrogen-containing medications. The Women’s Health Research Unit at Oregon Health Sciences University in Portland is researching use of ulipristal acetate as a potential contraceptive. Clinicians might be familiar with ulipristal acetate in its use as ella (Afaxys, Charleston, SC), approved for emergency contraception.
Several European and Latin American countries have seen the launch of a combined oral contraceptive (OC) containing a natural estrogen and a new progestin, nomegestrol acetate (NOMAC). Research indicates the combination pill is well-tolerated and provides effective contraception and acceptable cycle control.6 The pill is being marketed in approved countries as Zoely. Teva Pharmaceutical Industries Ltd. of Jerusalem, Israel, holds exclusive marketing rights for Zoely in France, Italy, Belgium, and Spain. MSD of Whitehouse Station, NJ, markets Zoely in all other European Union and other European countries. The drug is under review by the FDA. (To read more on the drug, see the CTU article, "New OC formulation now in research focus," July 2012, p. 78.)
In 2012, the European Commission approved Bayer HealthCare’s new low-dose combined oral contraceptive, Flexyess. The drug, which contains 3 mg drospirenone and 0.02 mg ethinyl estradiol, relies on a flexible extended regimen. Research indicates the flexible dosing regimen of the drug combination is tied to good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen.7
What’s the right method?
A 2013 report from the Centers for Disease Control and Prevention notes that among women of reproductive age who had had sexual intercourse, 47% of those who had ever used at least one contraceptive method had discontinued a method due to dissatisfaction.8
"While it should be possible to improve effective use, most interventions designed to improve compliance and continuation rates have proved surprisingly disappointing," stated Anna Glasier, MD, professor of obstetrics and gynecology at the University of Edinburgh, Scotland, at a presentation made at the Society for the Study of Reproduction 2014 annual meeting. "Contraception is most effective when the method makes no demands on compliance and when motivation to avoid pregnancy is high."9
What’s the next step? Those in reproductive health must be more imaginative in the strategies to improve patterns of contraceptive use and more rigorous in the research to evaluate them, stated Glasier.
REFERENCES
- Guttmacher Institute. Unintended pregnancy in the United States. Fact sheet. Accessed at http://1.usa.gov/1G9RqD.
- Haddad L. What makes LARC methods 1st tier choices? Hear the latest. Presented at the Contraceptive Technology Atlanta 2014 conference. Atlanta; October 2014.
- Adolescents and long-acting reversible contraception: implants and intrauterine devices. Committee opinion No. 539. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012; 120:983-988.
- Baram I, Weinstein A, Trussell J. The IUB, a newly invented IUD: a brief report. Contraception 2014; 89(2):139-141.
- Wiegratz I, Bassol S, Weisberg E, et al. Effect of a low-dose contraceptive patch on efficacy, bleeding pattern, and safety: a 1-year, multicenter, open-label, uncontrolled study. Reprod Sci 2014; 21(12):1518-1525.
- Bahamondes L, Bahamondes MV. New and emerging contraceptives: a state-of-the-art review. Int J Womens Health 2014; 6:221-234.
- Jensen JT, Garie SG, Trummer D, et al. Bleeding profile of a flexible extended regimen of ethinyl estradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception 2012; 86(2):110-118.
- Daniels K, Mosher WD, Jones J, Contraceptive methods women have ever used: United States, 1982-2010. National Health Statistics Reports 2013; accessed at http://1.usa.gov/1aSMgZX.
- Glasier AF. Increasing global contraceptive use. Presented at the Society for the Study of Reproduction 2014 annual meeting. Grand Rapids, MI; July 2014.
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