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News Release - April 16, 2008
Schering-Plough Announces Imperfect Contraceptive Use Impacts Women's Emotional Well-BeingStudy Published in April 2008 Issue of Contraception
KENILWORTH, N.J., April 16 (HSMN NewsFeed) -- Schering-Plough Corporation today announced results of a recently completed study showing that non-compliance with combined hormonal contraceptives has noticeable effects on women's emotional well-being, prompted requests for physicians' advice and led to increased use of emergency contraception. Results were presented today in Madrid, Spain, and were published earlier this month in Contraception.
The cross-sectional, multi center study was designed to assess the self-described impact of noncompliant behavior among 26,250 current users, aged 18 to 49, of three combined hormonal contraceptive methods, the combined pill, the skin patch and NUVARING® (etonogestrel/ethinyl estradiol vaginal ring), the vaginal ring.
"The study included questions about attitudes and psychological impact of inconsistent use of the contraceptive method when confronted with noncompliant behavior, an issue that has been poorly characterized in previous studies," commented Dr Inaki Lete, Hospital Santiago Apostol, Vitoria-Gasteiz, Spain and lead investigator. "These considerations will help health-care professionals to empower women to increase compliance with the prescribed contraceptive regimens."
The study found that 71 percent of pill users, 32 percent of patch users and 21.6 percent of ring users reported noncompliant behavior ( p<0.0001 for all comparisons). Between 10 and 20 percent of women reported that noncompliant behavior with their current method negatively affected work activities and their relationship with their partner, and about 3 percent had missed days of work or school. A higher percentage of pill users reported that they were 'worried' or 'scared' (68.8 percent and 22.6 percent respectively) compared with women using the skin patch (61.7 percent and 19 percent) or the vaginal ring (58.3 percent and 16.4 percent) (p<0.0001).
In addition to impacting women's emotional well-being, imperfect contraceptive use also had economic implications depending on the contraceptive method used. About 40 percent of women in all groups called or visited a physician because of birth control method non-adherence. 14 percent of pill users, 11 percent of patch users and 6.3 percent of ring users requested emergency contraception. 40 percent of the pill and patch users performed a pregnancy test compared with 29 percent of those using the vaginal ring.
Finally, after completing the questionnaire, 64.7 percent of pill users preferred the contraceptive pill, 61.7 percent of skin patch users preferred the transdermal patch and 96.6 percent of women using the vaginal ring preferred the ring. Compliance-related problems were the most important reason provided for contraceptive method change. A similar percentage of women in the pill and skin patch groups changed to the vaginal ring (31.6 percent and 32.9 percent, respectively), whereas among users of the vaginal ring only 1 percent changed to the pill and 3 percent to the skin patch.
About the study
The three-month study was carried out at outpatient clinics of the departments of gynecology and family planning centers of public and private institutions throughout Spain in 2006. In total 458 physicians participated. Women aged 18 to 49 years who were current users of one of the methods and consulted their physicians for a scheduled routine contraceptive visit were eligible, provided they gave written and informed consent and were able to understand and complete the study questionnaire. Non-compliant behavior was defined as missing or delays in the taking/ application/insertion or removal of the pill, patch or ring.
Overall, 65 percent of women taking part in the study were currently using the combined Pill, 23 percent the vaginal ring and 12 percent the skin patch. Among women who had been using their method for less than 18 months, 39.4 percent used the Pill, 39.1 percent the ring and 21.5 percent the patch.
The study also showed that following non-compliance, most women continued to use the same contraceptive method, between 55 and 63 percent waited for onset of bleeding and about 40 percent of the pill and patch users performed a pregnancy test compared with 29 percent of those using the vaginal ring. In addition, a higher percentage of pill and patch users (43.9 percent and 39.7 percent respectively) reported feeling relief at the start of their withdrawal bleed than ring users (20.2 percent) (p<0.05). Overall, 70 percent continued to have an active sex life and 60 percent used an additional contraceptive method.
The study protocol was approved by the Expert Committee on Contraception of the Spanish Society of Contraception. The study was supported by a grant from the Spanish Society of Contraception and Organon Spain.
NUVARING is a non-biodegradable, flexible, transparent colorless to almost colorless combination contraceptive vaginal ring. It is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NUVARING is highly effective if used as recommended in the label.
Developed by Organon, NUVARING was first licensed for use in the U.S. in 2002. The safety and efficacy of NUVARING, when used in accordance with product labeling, has been well established in clinical trials and through commercial experience. There are more than 1.5 million current users worldwide. In three large clinical trials of 13 cycles of NUVARING use, pregnancy rates were between one and two per 100 women-years of use.
NUVARING works by releasing a continuous low dose of hormones, on average 0.120 mg of etonogestrel (a progestin) and 0.015 mg of ethinyl estradiol (an estrogen), per day over a twenty-one day period of use.
NUVARING has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. Patients easily insert and remove NUVARING by using their fingers to press the sides of the ring together and gently push it into the vagina. The exact positioning of NUVARING within the vagina is not critical for the product to work because NUVARING is not a barrier contraceptive and therefore cannot be incorrectly inserted. Upon insertion, NUVARING begins to release a steady flow of hormones and works to prevent pregnancy on a monthly basis.
To prevent pregnancy for a full month, the vaginal ring must be inserted according to the instructions set forth in the product labeling and left in place for three consecutive weeks. This means that the ring is removed three weeks later on the same day of the week as it was inserted and at about the same time. NUVARING can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out. After a one-week break, during which a withdrawal bleed usually occurs, a new ring is inserted on the same day of the week as it was removed.
Important Safety Information
NUVARING® does not protect against HIV infection and other sexually transmitted diseases. The use of combination oral contraceptives is associated with increased risks of several serious side effects, including blood clots, which may lead to stroke or heart attack. NUVARING® is not for women with a history of these conditions or for women with certain cancers or those who may be pregnant. The risk of getting blood clots may be greater with the type of progestin in NUVARING® 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® use than with the use of certain birth control pills. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35; women who use combination hormonal contraceptives are strongly advised not to smoke. The most common side effects reported by NUVARING® users are vaginal infections and irritation, vaginal secretion, headache, weight gain, and nausea.
Please visit www.NUVARING.com for detailed patient information.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for NUVARING. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in Schering-Plough's 2007 10-K/A.
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