ROSELAND, N.J., Sept. 9 /PRNewswire-FirstCall/ -- -- Organon USA today announced that new data show that estrogen exposure with NuvaRing(R) (etonogestrel/ethinyl estradiol vaginal ring) is significantly lower than that achieved with the transdermal patch and an oral contraceptive. Additional data presented at the meeting demonstrate that women who use NuvaRing(R) place fewer follow up phone calls to healthcare professionals within the first three months of starting the method than women using oral contraceptives or the transdermal patch(1). The data were presented for the first time this week at Reproductive Health 2005, the joint annual meeting of the Association of Reproductive Health Professionals (ARHP), the Society of Family Planning (SFP), and Planned Parenthood(R) Federation of America’s (PPFA) National Medical Committee, in St. Petersburg, Florida. The pharmacokinetic data are also published in the September issue of Contraception(2).
The pharmacokinetic comparison of ethinyl estradiol (EE) released from the transdermal patch (Ortho Evra(R)3), an oral contraceptive (Microgynon(R)4) and NuvaRing(R) demonstrates that estrogen exposure with NuvaRing(R) was 3.4 times lower than observed with the patch and 2.1 times lower than observed with the oral contraceptive. Both differences were statistically significant. Such a three-way comparison of different hormonal contraceptives with different routes of administration has not been previously reported.
“Women using hormonal contraceptives can experience estrogen-related side effects, such as nausea and breast tenderness, but these side effects are highly preventable,” said Mitchell Creinin, M.D., Professor and Director of Family Planning, University of Pittsburgh School of Medicine. “NuvaRing(R) provides women with a safe and highly effective contraceptive method while continuously releasing less ethinyl estradiol through a vaginal route of administration. Low exposure to ethinyl estradiol not only maximizes tolerability, but also fits with our desires, as health care providers, to use the lowest effective dose possible of a medication.”
Results from the patient callback study reveal a significantly lower patient callback rate with NuvaRing(R) than several other popular contraceptives. Clinicians received the most callbacks with the transdermal patch (20/40) in the first three months of use, followed by oral contraceptives (30/96) and then NuvaRing(R) (11/72). Several patients using the patch and an oral contraceptive placed double callbacks to their healthcare providers; there were no multiple callbacks among NuvaRing(R) users.
“Patients and clinicians have similar goals for contraceptives, including efficacy, tolerability and a low incidence of side effects,” said Isaac Victor, M.D., Cranford, NJ. “For patients, lower callback rates likely suggest satisfaction with the method and few side effects, which can translate into better compliance. For clinicians, fewer patient callbacks may provide increased confidence in the contraceptive being prescribed.”
Lower Levels of Estrogen Exposure, Steadier Hormone Levels Seen with NuvaRing(R)
The randomized, open label study of 24 women -- “Comparison of Ethinylestradiol Pharmacokinetics in Three Hormonal Contraceptive Formulations: the Vaginal Ring, the Transdermal Patch and an Oral Contraceptive” -- found that exposure to estrogen with NuvaRing(R) was the lowest of the three contraceptives. Additionally, peak levels of ethinyl estradiol were significantly lower with NuvaRing(R) than the transdermal patch and oral contraceptive.
The study evaluated multiple measurements of ethinyl estradiol serum levels in women randomly assigned to use NuvaRing(R) (15 mcg EE/day), the transdermal patch (20 mcg EE/day) or a combined oral contraceptive (30 mcg EE/day). Women using NuvaRing(R) showed much lower fluctuation in serum estrogen levels -- commonly referred to as ‘ups and downs’ -- than the other contraceptives, signifying more stable and precise dosing with the vaginal administration of medication. As expected, women in the pill group showed the greatest degree of variation in serum concentrations.
In the study, a higher incidence of estrogen-related adverse events, such as nausea and breast tenderness, was observed in the transdermal patch group than the NuvaRing(R) and pill groups. All three options were well tolerated.
Fewer Patient Callbacks Reported with NuvaRing(R)
The study of 208 women at two sites in New Jersey and Florida -- “Comparing Patient Telephone Callback Rates for Different Hormonal Birth Control Delivery Systems” -- found a significantly lower patient callback rate with NuvaRing(R) in the first three months of use than women using the transdermal patch (Ortho Evra(R)2) and women using an oral contraceptive (monophasic and triphasic contraceptives under 50 mcg, with standard monthly withdrawal regimens). All three groups were significantly different from each other (P=0.0004).
In this study, most patients contacted their clinicians regarding side effects related to their contraceptive method. The leading reasons for patch callbacks included nausea, detachment and headache; for oral contraceptives, leading reasons included breakthrough bleeding and nausea; leading reasons for NuvaRing(R) callbacks included partner complaints and expulsion.
Women taking place in the study selected the contraceptive methods of their choice; all patients were given standard counseling and reference handouts. Participants had either never used or had discontinued hormonal contraception for at least one month prior to the study.
About NuvaRing(R)
NuvaRing(R) works by releasing a continuous low dose of estrogen and progestin, on average 0.120 mg of etonogestrel (a progestin) and 0.015 mg of ethinyl estradiol (an estrogen) per day over a 21-day period of use. The daily dose of estrogen delivered by NuvaRing(R) is less than any available combination hormonal contraception.
NuvaRing(R) has an outer diameter of two inches and a cross-sectional diameter of 1/8 inch. Patients easily insert and remove NuvaRing(R) by using their fingers to press the sides of the ring together and gently push it into and remove it from the vagina. The exact positioning of NuvaRing(R) within the vagina is not critical for the product to work because NuvaRing(R) is not a barrier contraceptive and therefore cannot be incorrectly inserted.
Like other hormonal contraceptives, NuvaRing(R) does not protect against HIV infection and other sexually transmitted diseases. The use of combination hormonal contraceptives is associated with increased risk of several serious side effects, including blood clots, which may lead to stroke or heart attack. The risk of getting blood clots may be greater with the type of progestin in NuvaRing(R) than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing(R) use than with the use of certain birth control pills. Cigarette smoking increases the risk of high blood pressure and heart disease; women who use combination hormonal contraceptives are strongly advised not to smoke. For more information, or full prescribing information, please visit http://www.nuvaring.com or http://www.organonusa.com.
About Organon
Organon -- with shared head offices in Roseland, NJ, USA and Oss, The Netherlands -- creates, manufactures and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia.
Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel NV.
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This report contains statements which address such key issues as Organon’s growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements, including but not limited to the “Outlook,” should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. These factors also include changes in regulations or interpretations related to the implementation and reporting under IFRS, decisions to apply a different option of presentation permitted by IFRS, and various other factors related to the implementation of IFRS, including the implementation of IAS 32 and 39 for financial instruments. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please see the Akzo Nobel Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Company’s website http://www.akzonobel.com.
* Pursuant to the U.S. Private Securities Litigation Reform Act 1995. 1. Victor I. “Comparing Patient Telephone Callback Rates for Different Hormonal Birth Control Delivery Systems”. Oral presentation presented at the 42nd Annual Meeting of the Association of Reproductive Health Professionals, September 7-10, 2005, St. Petersburg, FL. 2. Van den Heuvel MW, van Bragt AJM, Alnabawy A, Kaptein M. Comparison of Ethinylestradiol Pharmacokinetics in Three Hormonal Contraceptive Formulations: the Vaginal Ring, the Transdermal Patch and an Oral Contraceptive. Contraception. 2005; 72(3):168-174. 3. Ortho Evra(R) is a registered trademark of Ortho-McNeil Pharmaceutical 4. Microgynon(R) is a registered trademark of Schering AG
Organon USA
CONTACT: Frances DeSena of Organon Pharmaceuticals USA Inc.,+1-973-325-4500, f.desena@organonusa.com; or Amanda Mason of Fleishman-Hillard, +1-212-453-2465, masona@fleishman.com, for Organon PharmaceuticalsUSA Inc.
