Organon's NuvaRing is approved for birth control.
The effort to control unwanted pregnancies effectively and conveniently has turned a new page with the introduction of NuvaRing (Organon), a novel hormonal contraceptive vaginal device.
As the number of unwanted pregnancies is still on the rise in the United States, interest in curbing this growth is high. Pharmacists are in a leading position to assist patients in the selection of a contraceptive that takes into account the unique needs of each patient.
In clinical trials, all oral contraceptives are highly effective (> 99%) at preventing pregnancy if taken as prescribed. Unfortunately, actual pregnancy rates of 1% to 3% differ from those in clinical trials, primarily due to patient noncompliance. "Noncompliant patients who are currently taking an oral contraceptive pill may be more likely to experience breakthrough bleeding and possibly ovulation, which may lead to unwanted pregnancies," said Larry Seidman, D.O., clinical assistant professor, obstetrics and gynecology, MCP-Hahnemann School of Medicine in Philadelphia, a NuvaRing clinical investigator.
"For these patients, NuvaRing is a viable alternative hormonal contraception with increased convenience and protection," said Seidman. "Because the vaginal ring provides a month-long contraceptive protection, the patient does not have to remember to take a pill each day. The majority of the volunteers in the clinical study considered this new contraceptive method simple to use and were eager to inquire as to the eventual availability of the product."
Women can easily insert or remove the ring by pressing the sides of the circle together to gently push it into or remove it from the vagina. The correct positioning of the hoop is not critical because NuvaRing is not a barrier contraceptive. The small, flexible ethylene vinylacetate (EVA) ring is inserted on or before the fifth day of the menstrual period and designed to release a steady flow of low-dose etonogestrelthe biologically active metabolite of the progesterone desogestreland ethinyl estradiol (EE), the estrogen component (an average of 0.120 mg and 0.015 mg, respectively, per day) for over 21 days of use.
"Some of the noteworthy benefits of NuvaRing are the elimination of the first-pass effect with the attainment of steady-state blood levels of the hormones within three days of administration. Subsequently, this allows the use of the lowest effective dose with potentially lower adverse effects," noted Nancy Alexander, Ph.D., director of contraception medical services at Organon in West Orange, N.J. "Breakthrough bleeding that is known to occur with the use of some of the oral contraceptives was reported infrequently [2.6%-6.4% of evaluable cycles], and there were no birth defects throughout the clinical development," she said.
The safety and efficacy of NuvaRing have been studied in four worldwide clinical trials in which more than 2,300 women were exposed to the product. NuvaRing completely inhibited ovulation throughout the normal three weeks of use. Compliance with the prescribed regimen was high, and the pregnancy rate was extremely low. It must be noted, however, that NuvaRing does not offer protection against any sexually transmitted disease, including HIV.
Adverse events were infrequent and similar to those reported with other combination oral contraceptive methods. The most common adverse events, reported by 5% to 14% of women using NuvaRing, were increased vaginal discharge, vaginitis, headache, upper respiratory tract infection, weight changes, and nausea.
"Events that caused discontinuation of use include expulsion of the ring and coital discomfort [i.e., the ring was felt by the partner]," said Seidman. "However, most women reported no discomfort during intimacy. If desired, NuvaRing can be removed for up to three hours."
The most serious adverse effects associated with the use of hormonal contraceptives, such as stroke, myocardial infarction, and thrombosis, occur mostly in women over 35 who smoke more than 15 cigarettes a day. Combination contraceptive users are strongly advised not to smoke.
Initially, NuvaRing will be introduced free of charge in the United States through about 6,000 OB-GYN practitioners in the fourth quarter of this year. Organon plans to make NuvaRing available in pharmacies nationwide by June 2002. "The cost of the product will be in line with the once-a-month injectable contraceptives," said Alexander.
This innovative drug delivery technology may provide improvement in other therapeutic areas. For instance, a vaginal ring is under study for managing the symptoms of menopause.