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Bayer low-dose contraceptive patch for women in late-stage human testing

Tuesday, May 5, 2009, 10:45 This news item was posted in health category and has 0 Comments so far.

 

New contraceptive patch for women needs to be applied only once per week.

A low-dose hormone contraceptive patch for women developed by Bayer is currently in last phase of human studies.

The new patch will contain very low doses of hormones ethinylestradiol and gestodene, unlike the currently available contraceptive pills containing high doses of sex hormones.

The new contraceptive patch for women has other benefits also. The patch needs to be applied only once per week. In other words, women who look for contraception would require only three patches per cycle (for 21 days) and one week off.

The simple nature of the female contraceptive patch will make it more convenient to use. Bayer Schering Pharma AG, the makers of the new patch is very hopeful of better compliance from women as the patch is easy to handle and avoid s the needs to be taken orally everyday – the manner in which the conventional pills are taken.

“Bayer Schering Pharma is looking forward to progressing to Phase III trials with our novel patch. It will be the smallest, lowest dosed and the only transparent patch for female contraception on the market,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma. “We are optimistic that these attributes will make it an attractive option for women seeking alternative routes of hormonal contraception.”

Bayer Schering Pharma AG, Germany is starting Phase III -the final phase of human studies before applying for market approval — with the new contraceptive patch for women this month.

The hormone patch will be tested approximately on 3300 women who will be enrolled into two global studies to evaluate the contraceptive reliability of the patch.

 

Bayer Schering Pharma AG expects to complete the studies in two years and file for the regulatory approval of the new patch in 2012. Bayer Schering Pharma AG plans to submit the new hormone contraceptive patch for registration worldwide.

 

Ethinylestradiol and Gestodene

 

Ethinylestradiol is the first orally active synthetic steroidal estrogen. It contains  (17?-ethynylestradiol), the 17?-ethynyl analog of estradiol. Ethinyl estradiol binds to the estrogen receptor complex and enters the nucleus, activating DNA transcription of genes involved in estrogenic cellular responses.

Ethinylestradiol also inhibits 5-alpha reductase in epididymal tissue, which lowers testosterone levels and may delay progression of prostatic cancer. Ethinyl estradiol protects against osteoporosis. In animal models, short-term therapy with this agent has been shown to provide long-term protection against breast cancer, mimicking the antitumor effects of pregnancy

Gestodene is a newer synthetic progestogens. Gestodene was developed in an attempt to produce agents with more selective progestational activity that would improve cycle control and minimise metabolic changes and adverse events while effectively preventing pregnancy. 

In clinical practice, gestodene is combined with ethinylestradiol in monophasic or triphasic combined oral contraceptive preparations. Gestodene has pharmacokinetic advantages over the other new progestogens in that it is active per se (the others are prodrugs) and has high bioavailability (approximately 100%). The ability of gestodene-containing oral contraceptives to inhibit ovulation is similar to that of preparations containing other progestogens although the required dosage is lower. In common with oral contraceptives containing desogestrel or norgestimate, and in contrast with those containing levonorgestrel, gestodene-containing preparations are associated with neutral or positive changes in lipid and carbohydrate metabolism. Pregnancy rates with gestodene-containing preparations are low .

Some of the common drug formulations (pills) containing ethinylestradiol and gestodene combination include Schering-Plough’s Femoden ED, Melodene tablets, Mirelle tabs, Triodene ED ED tablets and Wyeth-Ayerst Pharmaceuticals’ Minesse.

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare.

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