MedicalResearch.com Interview with:
Senior Director, Clinical Development
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Lotus I study provides clinical evidence that oral dydrogesterone is a treatment option for women who undergo in vitro fertilization (IVF) treatment. The current standard of care for IVF globally is micronized vaginal progesterone (MPV), which is administered vaginally.
The Lotus I study concludes that oral dydrogesterone is similarly well-tolerated and efficacious compared to MVP, while being easier to administer than MVP.
MedicalResearch.com: What should readers take away from your report?
Response: The study findings may pave the way for an additional progesterone treatment option for the estimated 1.5 million women worldwide who undergo IVF treatment each year.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Dydrogesterone has been marketed for more than 50 years for conditions related to progesterone insufficiency. The safety and tolerability profile has been well-established through the experience of an estimated > 94 million patients globally and a number of randomized clinical trials.
MedicalResearch.com: Is there anything else you would like to add?
Response: We will apply for regulatory approval of this indication in all markets in which we operate. At present this indication is not approved in any country.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
8 Tournaye H, Sukhikh G, Kahler E, and Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Human Reproduction. 2017
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