Jayne Ritz

 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 etonogestrelthe biologically active metabolite of the progesterone   desogestreland 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. 

 NuvaRing should be inserted on or before the fifth day of the menstrual     period. 

NuvaRing does not protect against sexually transmitted diseases. 

Articles

Organon's NuvaRing is approved for birth control.