Bayer's Canadian contraception family is growing with the launch of Kyleena®

Kyleena is an effective, low-dose, five-year birth control option that women don't have to worry about taking every day. 

TORONTO, March 20, 2017 /CNW/ - Canadian women have a new, effective and reversible way to prevent pregnancy with the launch of Kyleena, a new intrauterine system (IUS).¹ Kyleena (LNG-IUS 19.5 mg) releases a low daily hormone dosage of levonorgestrel using the smallest T-body available in a five-year IUS.

Despite the multitude of contraceptive options available to women, unintended pregnancy remains high in North America.² Kyleena may be a suitable alternative for women because she gets reliable contraception that she doesn't have to worry about taking every day.³

“The launch of Kyleena helps to address the need for long-term contraception among women across the reproductive spectrum by offering a small IUS and a low daily hormone dosage for use up to five years,” said Dr, Dustin Costescu, MD. “I encourage open and honest dialogue about birth control options with my patients so that they feel empowered to choose the birth control that is right for their lifestyle. The introduction of Kyleena is a significant addition to that conversation.”

Kyleena is a form of long acting reversible contraceptive (LARC). LARC methods offer the highest effectiveness and highest continuation rates at one year, since they are effective independent of any action by users on a daily or monthly basis.⁴ Kyleena is not reliant on daily user compliance. Kyleena has proven more than 99 per cent efficacy at preventing pregnancy for each year of use in clinical trials and is suited to women regardless of whether they have had children.⁵ 

Kyleena does not contain any estrogen and works by slowly releasing a low amount of a hormone called levonorgestrel directly into the uterus every day. Levonorgestrel is similar to a sex hormone produced naturally by the body.⁶ Kyleena may work to prevent pregnancy in several ways including: reducing the monthly thickening of the lining of the uterus; thickening the mucus in the cervix (this makes it harder for sperm to pass through the cervix); impairing sperm movement and function. Together, these actions prevent the sperm and egg from coming into contact and work together to prevent pregnancy.⁷

“The launch of Kyleena not only gives Canadian women more contraceptive options, but another highly effective option,” added Dr. Costescu. “Women are encouraged to take an active role and engage their health care providers to explore all birth control options and find the option that works best for her lifestyle.”

Kyleena can be removed at any time by a healthcare professional. Kyleena does not alter the course of future fertility and upon removal women return to their normal fertility.⁸

For more information on Kyleena, please visist: http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.

About the Clinical Development Program for Kyleena

The contraceptive efficacy of Kyleena has been evaluated in a multi-centre (Europe, North America, and South America), openlabel, randomized clinical study for 3 years with an extension to 5 years. The study included 1452 women aged 18-35 including 39.5 % (574) nulliparous women of whom 84% (482) were nulligravid using KYLEENA. Approximately 40% of women in this study were 25 years or younger.⁹

The primary endpoint of the Phase III clinical trial program was contraceptive efficacy assessed by the Pearl Index. With a Pearl Index of 0.29 after five years in clinical trials, for each year of use, Kyleena is more than 99 percent effective in preventing pregnancy for women who desire a low-dose, long-acting contraceptive option for up to five years.

Of the 1452 women treated with Kyleena, 1445 (99.5%) had a successful insertion. The first insertion attempt was successful in 1390/1452 women (95.7%); the second attempt was successful in 55/57 (96.5 %) women. Study investigators assessed the insertion procedure as easy in 1302/1452 women (89.7 %). The insertion procedure was evaluated as easy in 84.3% and 93.2% of nulliparous and parous women, respectively.

Most women experienced either no pain (18.5%, 268/1452) or only mild pain (47.0%, 683/1452) during insertion of Kyleena. A total of 400 (27.5 %) women experienced moderate pain and 100 (6.9%) experienced severe pain. There was a trend towards less pain in parous women compared to nulliparous women.

Moreover, Kyleena was generally well tolerated, with no unexpected adverse events reported compared to other LNG-IUS. Low incidences of ectopic pregnancy, pelvic inflammatory disease, expulsion of the system from the uterus and uterine perforation were seen.¹⁰

About Bayer in Women's Healthcare

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. With a long heritage in Women's Healthcare, Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases with several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way how women's health related conditions are treated.

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.ca.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer 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.

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1	Kyleena Product Monograph. December 9, 2016 http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.
2	Guilbert E et al. Missed hormonal contraceptives: new recommendations. J Obstet Gynaecol Can 2008; 30(11): 1050-62.
3	birthcontrolforme.ca
4	Black A et al. Canadian Contraception Consensus (Part 1 of 4). J Obstet Gynaecol Can 2015;37(10):936-42
5	Kyleena Product Monograph December 9, 2016.. http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.
6	Kyleena Product Monograph.December 9, 2016. http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.
7	Kyleena Product Monograph December 9, 2016. http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.
8	Kyleena Product Monograph. December 9, 2016. http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.
9	Kyleena Product Monograph. December 9, 2016. http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.
10	Kyleena Product Monograph. December 9, 2016. http://omr.bayer.ca/omr/online/kyleena-pm-en.pdf.

SOURCE Bayer Inc.

For further information: Media Contact: Jessica Swan, Narrative, 647-281-6345, E-Mail: [e-mail]