1 June 2020This updated Medicines Q&A evaluates the available evidence regarding an interaction between St John’s Wort and combined and progestogen only hormonal contraceptives. Summary The interaction…
25 March 2020PGD templates for commonly supplied/administered methods of contraception have been developed by an SPS led working group with support from the FSRH.
Apleek, LisvyContraception transdermal patch
Development and Regulatory status
Licensed but not launched
Phase III Clinical Trials
Apr 20No update available on company website re plans for launch of Apleek, Lisvy. It is also unclear whether the product is still being marketed in the EU [16,17].
Mar 19In its latest annual report, Luye notes their acquisition of Apleek and with respect to its sales and marketing activities, will focus its marketing and promotion resources on the regions and products where marketing and promotion expenditure yields higher returns, thereby increasing its overall sales efficiency. Luye has an office in the UK, but no mention is made of specific UK launch plans .
Aug 18Luye Pharma acquires global rights for ethinylestradiol/gestodene from Bayer. Gedeon Richter has previously entered into a license and distribution agreement with Bayer to commercialise ethinylestradiol/gestodene transdermal in the EU, in other European countries and in certain Latin American countries. Luye plans to launch the product in the US, the EU, China, Japan and other global emerging markets with potential demands [13,14].
Dec 17No update available on plans for Lisvy .
Dec 17Lisvy was also approved by the MHRA in 2014 .
Oct 16Following a notification received from Bayer HealthCare that certain stability tests carried out under specific conditions had resulted in out-of specification results, Richter initiates the voluntary withdrawal of Lisvy in all markets involved .
Jan 15Gedeon Richter announces that national marketing approvals had been granted in the majority of European countries .
Jan 15Hungarian company Richter has entered a license and distribution agreement with Bayer HealthCare to sell a transdermal contraceptive patch in Europe 
Feb 14Approved via the decentralized European registration procedure. The Health Authorities of the EU Member States will now grant national approvals for the product .
Sep 12Filed in the EU. France will serve as the reference member state in the decentralized EU procedure .
Low-dose, monophasic preparation of combined ethinylestradiol/gestodene for once weekly delivery, i.e. three patches per cycle (for 21 days) and one-week off
75% of women aged 16-49 years use some type of contraception. 25% of women use the combined oral contraceptive pill .
Contraception transdermal patch
Trial or other data
Sep 12The contraceptive patch is small, round and transparent and contains 0.55mg ethinylestradiol and 2.1mg gestodene. The systemic exposure is the same as observed after daily administration of a combined oral contraceptive containing 0.02mg ethinylestradiol and 0.06mg gestodene .
Sep 11One of two PIII global studies (NCT00914693) recruiting 1,694 women completes .
Feb 11A US-based trial enrolling 1,502 subjects (NCT00910637) completes. Another PIII trial comparing the ethinylestradiol/gestodene (0.55mg/2.1mg) transdermal patch with oral ethinylestradiol/levonorgestrel (20µg/100µg) in a 21-day regimen for seven cycles (NCT00920985) in 342 US women in the US also completed in Sep 10 .
Nov 10Bayer completed a randomised, open-label PIII trial (NCT00984789) in 400 healthy women in Austria, the Czech Republic & the Netherlands. The trial compared the ethinylestradiol/gestodene patch with norelgestromin/ethinylestradiol, in terms of patterns of menstrual bleeding, effectiveness at preventing pregnancy, general safety & tolerability .
May 09Approximately 3300 women will be enrolled into two global PIII studies to evaluate the contraceptive reliability of the patch. The company state that it will be the smallest, lowest dosed and the only transparent patch for female contraception on the market. It will be applied once per week, i. e. three patches per cycle (for 21 days) and one week off. It is planned to submit the new patch for registration worldwide (1).