Organon launches NuvaRing, first combined contraceptive vaginal ring
Limited distribution now in effect — look to June 2002 for wider access
You review your patient’s contraceptive history. A candidate for combined oral contraceptives (OCs), she has struggled with maintaining a daily pill regimen. What are her options for safe, effective birth control?
Add the NuvaRing combined contraceptive vaginal ring from West Orange, NJ-based Organon to the list of family planning options. The device, the first of its kind to be introduced in the United States, received approval from the Food and Drug Administration Oct. 3. U.S. women are the first to have access to the new method, confirms Frances DeSena, Organon spokeswoman. (Contraceptive Technology Update reviewed the NuvaRing in the following issues: May 1998, p. 57; May 2001, p. 49; and August 2001, p. 88.)
"For decades, there has been a limited choice in convenient, reliable, and reversible contraception in the U.S.," says Wayne Shields, president and CEO of the Washington, DC-based Association of Reproductive Health Professionals. "NuvaRing gives women another safe, effective contraceptive option."
A flexible, transparent, colorless vaginal ring, the NuvaRing measures approximately two inches in diameter, with a cross-sectional diameter of about 1/8 inch. It releases a continuous low dose of the estrogen ethinyl estradiol and the progestin etonogestrel at an average rate of 0.120 mg of etonogestrel and 0.015 mg of ethinyl estradiol per day over a 21-day period of use. The woman inserts the ring in the vagina, leaves it in for three weeks, and then removes the device for one week during which she will have her menstrual period.
Since the NuvaRing is not a barrier contraceptive, its exact positioning within the vagina is not critical for its effectiveness. This ability for the woman to insert the device herself and rely on its effectiveness is a strong advantage to its use, says Phyllis Marx, MD, an independent investigator with the Chicago Center for Clinical Research and in private practice at Women’s Health Group in Skokie, IL.
"Ultimately, all you have to do is to remember to put [the device] in and take it out, and that is only once a month for each of those things," Marx observes. "So for people who have trouble remembering [to take OCs], the NuvaRing is really an advantage."
Initial distribution of the drug is currently limited to 6,000 U.S. providers who are now enrolling in Organon’s "premier provider" plan, says DeSena. (Editor’s note: Final details were under way as of Contraceptive Technology Update’s press time.) The company is distributing a limited number of rings to the enrolled providers while it expands its manufacturing capacity to deliver the new technology, she explains. Consumer launch of the prescription product is scheduled for mid-2002, says DeSena.
Provider inquiries about program enrollment may be directed to a toll-free number, (888) 427-1177. In addition, a company-sponsored web site, www.nuvaring.com, and toll-free telephone number, (877) NUVARING [(877) 688-2746] carry product information for patients and providers.
While a final price for the NuvaRing has not yet been set, company officials say cost of the device will be comparable to combined pill costs.
Clinical trials of the device were conducted in the United States, Canada, Europe, and Israel by Organon’s parent company, NV Organon of the Netherlands. The company plans to introduce the NuvaRing in other countries, says DeSena.
In a one-year, multicenter study, 1,145 women were exposed to the vaginal ring for 12,109 cycles (928 woman-years).1 Six pregnancies occurred during treatment, giving a Pearl Index of 0.65 (95% confidence interval 0.24-1.41). Cycle control was good, with rare irregular bleeding (2.6%-6.4% of evaluable cycles) and low withdrawal bleeding (mean duration 4.7-5.3 days) occurring in 97.9%-99.4% of evaluable cycles. Compliance to the prescribed regimen was high with criteria being fulfilled in 90.8% of cycles, report investigators.
The most common side effects reported by NuvaRing users are vaginal infections and irritation, vaginal discharge (leukorrhea), headache, weight gain, and nausea. The device does not protect against HIV infection and other sexually transmitted diseases.
Who is a candidate?
Any woman who currently is using combined OCs may use the NuvaRing, says Marx. (See "Who Should Not Use NuvaRing?," for a list of conditions that caution against NuvaRing use.)
When talking with women about use of the NuvaRing, remind them that the NuvaRing is NOT:
- a pill;
- a barrier device (like a diaphragm);
- a method of preventing HIV infection or sexually transmitted diseases;
- a daily contraceptive method.
As with oral contraceptives, NuvaRing may increase the risk of blood clots, heart attack, and stroke. These risks indicate that women over age 35 who smoke should be discouraged from using the NuvaRing, exactly as they are advised not to use combined oral contraceptives or the combined injectable, Lunelle (Pharmacia Corp., Peapack, NJ), says Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta.
Device is easy to use
The woman can insert the NuvaRing when she is lying down, squatting, or standing with one leg up. Holding the device between the thumb and index finger so that the opposite sides of the ring are pressed together, the NuvaRing is gently pushed into the vagina. The exact position of the ring is not important for it to work, according to the patient package insert.
Although some women may be aware of the NuvaRing in the vagina, most women do not feel it once it is in place, states the package insert. If the woman feels discomfort once the device is inserted, the NuvaRing probably is not inserted far enough into the vagina. According to the insert, there is no danger of the NuvaRing being pushed too far up in the vagina or getting lost; the device can be inserted only as far as the end of the vagina, where the cervix will block it from going any further.
Instruct on use
If NuvaRing is used according to package directions, the chance of getting pregnant is about 1%-2% a year, states the package insert. However, risks increase if the device is improperly used, the insert states. Pregnancy must be ruled out if the NuvaRing user:
- misses a menstrual period and the device was out of the vagina for more than three hours during the three weeks of ring use;
- misses a period and the user had waited longer than one week to insert a new ring;
- followed the package instructions, yet missed two periods in a row;
- left NuvaRing in place for longer than four weeks.
Problems with the NuvaRing are low, according to Organon. More than 90% of the women who completed the NuvaRing trials reported they were satisfied with the device at the end of the study.
"This is one of the few studies in which I have been involved where people have actually called back and tried to find out when [the method] is coming on the market because they had such success with it," says Marx. "They really liked it."
Reference
- Roumen FJ, Apter D, Mulders TM, et al. Efficacy, tolerability, and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod 2001; 16:469-475.
Who Should Not Use NuvaRing?
Patients should not use NuvaRing if they have any of the following conditions:
- pregnancy or suspected pregnancy;
- blood clots in the legs (thrombosis), lungs (pulmonary embolism), or eyes (now or in the past);
- chest pain (angina pectoris);
- heart attack or stroke;
- severe high blood pressure;
- diabetes with complications of the kidneys, eyes, nerves, or blood vessels;
- headaches with neurological symptoms;
- known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina (now or in the past);
- unexplained vaginal bleeding;
- yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during past use of oral contraceptives;
- liver tumors or active liver disease;
- disease of the heart valves with complications;
- need for a long period of bed rest following major surgery;
- an allergic reaction to any of the components of NuvaRing.
Source: NuvaRing patient package insert, Organon, West Orange, NJ.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content