Bayer introduces JAYDESS®, a simple and safe alternative to the 'Pill'
TORONTO, June 9, 2014 /CNW/ - When it comes to contraception, there's a shocking but real statistic: nearly half of all pregnancies in North America are unintended and of those unintended pregnancies, in Canada, almost one quarter end in abortion.i,ii Those numbers are even higher in women under the age of 30, with nearly 70 per cent of induced abortions occurring in this age group.iii
Unfortunately, a major contributor to these statistics is an inconsistent or incorrect use of birth control methods. In Canada, one third of women do not use contraception consistently. iv On average, oral contraceptive users miss 2.6 pills per cycle.v With this in mind, it's important for women to have access to birth control options that are reliable and easy to use.
Recently approved for use by Health Canada, Jaydess offers women conception control for up to three years and is more than 99 per cent effective. This new long-term, reversible contraceptive option offers a more convenient alternative to commonly used daily options like the birth control pill.
"We know women forget to take their pill, so a long-term contraceptive option like Jaydess can give women peace of mind and freedom from worrying about a daily routine," said Dr. Natashia Grell, a Toronto-based physician specializing in women's health. "Unintended pregnancies can have a devastating effect for some women and I feel it's important for women to understand all the contraceptive methods that are available to them so together with their physician they can make the best choice for their lifestyle. Offering a solution that takes the guesswork out of contraception makes it much easier for women to stay on track with their life goals."
A flexible plastic T-shaped device, Jaydess contains a low dose of the hormone levonorgestrel, which is slowly and continuously released locally in the uterus. Once Jaydess is removed, women can expect the return of their previous level of fertility.
TV personality Aliya-Jasmine Sovani – no stranger to speaking to young Canadians about issues that matter – feels it is important to foster a conversation about women's health and for them to stay on track with their life goals.
"I found the high number of unintended pregnancies that happen here in Canada really surprising when you consider how many options are available to us," said Sovani. "Women should be able to choose when they are ready to have children, and now there is an easier way for them to stay on track with those plans."
Jaydess is an intrauterine system (IUS) approved by Health Canada for the prevention of pregnancy (conception) for up to three years. Jaydess consists of a small white T-shaped frame made from soft, flexible plastic with a reservoir that contains a total of 13.5 mg of levonorgestrel released slowly and continuously into the uterus over three years.
Very common (≥10%) side effects include: headache, abdominal/pelvic pain, acne/oily skin, bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent or absent periods, ovarian cysts and vulvovaginitis (inflammation of the external genital organs or vagina).
Common (≥1% to <10%) side effects include: depressed mood, migraine, nausea, hair loss, upper genital tract infection, breast pain/discomfort, device expulsion (complete and partial), and genital discharge.
There is an increased risk for pelvic inflammatory disease (PID) in the first three weeks after the insertion of an IUS. Ectopic pregnancy (development of a fertilized egg outside the uterus) is possible when using Jaydess, as it is in women using no contraception. However, if a woman accidently becomes pregnant while using Jaydess, an ectopic pregnancy is more likely. Ectopic pregnancy is a serious condition. Therefore, she should tell her doctor if she has lower abdominal pain, especially if she has missed a period and/or has unexpected bleeding, since these can be signs of an ectopic pregnancy. In rare cases (occurring at a rate of 1/1,000 and 1/10,000), and most often occurring during insertion, Jaydess may perforate (punch a hole in) the wall of the uterus. If this happens, Jaydess must be removed. The risk of perforation is increased in breast-feeding women.
Jaydess does not protect against sexually transmitted infections (STIs) including HIV/AIDS. For protection against STIs, it is advisable to use condoms in combination with Jaydess. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Women should be counseled not to smoke.
About the Clinical Development Program for Jaydess
The approval of Jaydess is supported by data from a Phase III trial of 2,884 women aged 18-35. There were 1,432 women who received Jaydess, of whom 39 per cent (556) had not yet had a child. The study was a multicenter, multi-national randomized open-label study conducted in 11 countries including Europe, Latin America, the United States and Canada.
The Pearl Index – which measures the effectiveness of contraception – was the primary efficacy endpoint used to assess contraceptive reliability. The data showed that Jaydess is more than 99 percent effective in preventing pregnancy.
About Bayer in Canada
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate headquarters for the Canadian operations. Founded in 1863, Bayer AG is an international research-based group with core businesses in healthcare, crop science and innovative materials committed to creating a better life for all through science.
In Canada, Bayer operates its healthcare business – Pharmaceuticals, Consumer Care, Diabetes Care, Animal Health and Radiology & Interventional – from its headquarters in Toronto, ON, and Bayer CropScience Inc. operates out of its head office in Calgary, AB. Together with its material science business, Bayer improves the quality of life for Canadians through products that fight disease, protect crops and animals, and provide high-performance materials for numerous daily life uses.
With more than 1,300 employees across the country, in 2013, Bayer had sales of $1.6 billion and invested $61 million in research and development in Canada. Globally, Bayer AG had sales of €40.2 billion and invested €3.2 billion in research and development.
For more information about Bayer, please visit www.bayer.ca.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
i Singh S et al. Unintended pregnancy: worldwide levels, trends, and outcomes. Stud Fam Plann 2010; 41(4):241-250. S Singh S et al. Stud Fam Plann 2010; 41: 241-250.
ii Statistics Canada, Pregnancy Outcomes 2005, Catalogue no. 82-224-X
iii Statistics Canada, Pregnancy Outcomes 2005, Catalogue no. 82-224-X
iv Black A et al. Contraceptive use among Canadian women of reproductive age: results of a national survey. J Obstet Gynecol Can 2009; 31(7):627-640.
v Potter L, Oakley D, de Leon-Wong E, Cañamar R. Measuring compliance among oral contraceptive users. Fam Plann Perspect. 1996; 28(4):154-158.
vi Jaydess Product Monograph, November 2013
SOURCE: Bayer Inc.