Contraception focus: Combined hormones
The contraceptive vaginal ring (NuvaRing, Merck & Co., Whitehouse Station, NJ) and the contraceptive patch (Evra, Ortho Women's Health & Urology, Raritan, NJ) offer two options for women who choose combined hormonal methods. Results of the 2013 Contraceptive Technology Update Contraception Survey indicate that use of both methods is consistent with 2012's figures, with 95% of respondents indicating prescription of rings at their facilities and 70% noting patch use.
Executive Summary
Results of the 2013 Contraceptive Technology Update Contraception Survey indicate that use of the NuvaRing contraceptive vaginal ring and the Evra contraceptive patch is consistent with 2012's figures. More than 90% of respondents prescribe rings at their facilities, and 70% use patches.
- The Population Council is preparing to submit a New Drug Application to the Food and Drug Administration for its investigational one-year vaginal contraceptive ring. The ring contains ethinyl estradiol and the council's proprietary progestin, Nestorone.
- Soft and flexible, this investigational ring may be easily inserted and removed by the woman herself. Each ring is intended to be left in place for 21 days and removed for seven days, for up to 13 cycles (one year).
"NuvaRing is stocked and available, but we only distribute two rings at a time to those who do not have insurance and cannot get it with a prescription," states Dianne Rafferty, CNP, director of nursing at the Family Planning Association of Northeast Ohio in Painesville. "The response is good but would probably be better if we could distribute more at a time, but cost prohibits."
Clinicians at Planned Parenthood Southeastern Virginia in Virginia Beach don't actually dispense Evra and NuvaRing, but do write prescriptions, reports Karen Albright, WHNP-BC, lead clinician. Many patients would love to use NuvaRing, but most insurance companies will cover only contraceptives that have a generic option, she notes. "NuvaRing at a pharmacy is at least $80 or more per month, and my patients can't afford that," Albright states.
Interest in the contraceptive patch has waned, says Donna Gray, CNM, WHNP, a clinician at the Wyoming County Health Department's Men's and Women's Reproductive Health Services in Silver Springs, NY. "Evra was very popular about eight years ago. I use to have cases of it; now only a few women want it," Gray observes. "I think mostly [it is] because it can be seen and it leaves a mark when removed."
According to Contraceptive Technology, the weekly contraceptive patch and the monthly vaginal contraceptive rings are effective in clinical trials. Of 1,000 women using the patch or ring, only 12 will become pregnant within a year.1 Both methods fall in the second tier of contraceptive effectiveness, with higher failure rates than those of intrauterine devices and implants. Neither method requires daily use, which could facilitate consistent and correct use.1
The New York City-based Population Council is preparing to submit a New Drug Application to the Food and Drug Administration for its investigational one-year vaginal contraceptive ring. The ring contains ethinyl estradiol and the progestin Nestorone. Soft and flexible, this investigational ring may be easily inserted and removed by the user. Each ring is designed to be left in place for 21 days and removed for seven days, for up to 13 cycles (one year).
Results of one pivotal Phase 3 trial were presented at the October 2013 meeting of the American Society of Reproductive Medicine.2 The multicenter, open-label trial involved more than 1,100 healthy, normally ovulating women ages 18-40 across 12 study sites in Australia, Europe, Latin America, and the United States.
Preliminary results suggest the ring is effective in preventing pregnancy when used as directed. Its safety profile is consistent with available combined hormonal contraceptives. Most women experienced regular (scheduled) bleeding during the seven-day period when they were not using the vaginal ring. Reports of unscheduled (irregular) bleeding were infrequent, researchers report. All women participating in the return to fertility study returned to menses within six months after study completion.2
The study also assessed women's acceptance of the ring. Results indicate that women were satisfied with the device, found it easy to use, and would recommend it to other women.2
If approved by regulatory authorities, this investigational ring would offer a unique contraceptive option to women who want to limit or delay pregnancy, says Ruth Merkatz, PhD, director of clinical development for the Population Council's Reproductive Health Program. This long-acting reversible contraceptive method is intended to not require refrigeration, and it does not require insertion or removal by a healthcare professional, she notes. It is designed to be under the woman's control, and therefore, could be well-suited for women in low-resource settings who want contraception but very often are unable to obtain it. "In these settings, women often lack convenient access to a healthcare facility or pharmacy, and live in areas where access to reliable electricity is a challenge," state Population Council researchers.
The Population Council also is studying the acceptability of a three-month progesterone vaginal ring in low-resource settings to understand what women and their providers think about the method. The ring, which uses natural progesterone, is approved for breastfeeding women in eight Latin American countries as a safe and effective method for spacing pregnancies. According to the World Health Organization, spacing pregnancies is an important strategy to promote the health of postpartum mothers and their children.3
"Our mission is to develop and help expand access to contraceptive technologies where high-quality, voluntary family planning services are scarce or nonexistent," said Peter Donaldson, Population Council president in a statement accompanying the study presentation. "The council's one-year contraceptive vaginal ring is a promising new technology; we look forward to furthering its development to meet the needs of underserved women."
- Nanda K. Contraceptive patch and vaginal contraceptive ring. In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
- Merkatz R, Hoskin E, Sussman H, et al. Efficacy, safety and acceptability of a new contraceptive vaginal ring delivering Nestorone (150 mcg) and ethinyl estradiol (15 mcg) daily: results from a multi-center open label Phase 3 clinical trial. Presented at the 69th annual meeting of the American Society of Reproductive Medicine. Boston; October 2013.
- World Health Organization. Programming strategies for postpartum family planning. Accessed at http://bit.ly/MBPjBl.
