ABBOTT PARK, Ill., March 8, 2017
/PRNewswire/ -- New study results published in Human
Reproduction could pave the way for an additional treatment
option for the estimated 1.5 million women worldwide who undergo in
vitro fertilization (IVF) treatment each year1,
2. In the Lotus I study, which involved more than 1,000 women
across 38 international sites, oral dydrogesterone had similar
efficacy and tolerability to micronized vaginal progesterone (MVP),
which is the current standard of care globally to prepare the
uterus lining for pregnancy3.
IVF is one of several methods of assisted reproduction
technology whereby a fertilized embryo is transferred to the
woman's uterus4. Progesterone or a related hormone, such
as dydrogesterone, is used in IVF to prepare the lining of the
uterus (luteal phase support) to allow a fertilized egg to
implant5,6.
MVP is the most commonly used method of administering
progesterone in IVF centers globally7, but is associated
with side effects, such as irritation and discharge, as well as
poor patient acceptance6.
Lotus I, a Phase III randomized controlled clinical
study8, evaluated the effects of oral dydrogesterone in
luteal support in IVF. The findings of the study provide clinical
evidence for an oral treatment option. Besides its ease of
administration, the Lotus I study concluded that oral
dydrogesterone is similarly well-tolerated and efficacious compared
to MVP.
"The findings from this study have the potential to have
important implications for women undergoing IVF," said Herman
Tournaye, M.D., Ph.D., Director of the Center for Reproductive
Medicine at Universitair Ziekenhuis Brussel, and lead clinical
researcher for the Lotus I study. "We found oral dydrogesterone to
be effective, well tolerated and easy to administer – all of which
point to it becoming the new preferred treatment option."
In the Lotus I study, oral dydrogesterone achieved similar
results to MVP in terms of the presence of fetal heart beats at 12
weeks gestation, representing an ongoing pregnancy. Similar
findings also were observed in both treatment groups for the
study's secondary objectives of pregnancy and live birth
rates.
The results from the Lotus I study add to the body of evidence
from smaller IVF studies of the benefits of using oral
dydrogesterone for luteal support as part of IVF.
Abbott manufactures oral dydrogesterone for countries outside of
the United States; it is not
available in the United
States.
Lotus I Study Findings
The Lotus I study achieved its
primary efficacy endpoint, demonstrating non-inferiority of oral
dydrogesterone versus MVP with the presence of fetal heartbeats at
12 weeks of gestation. Results were similar between the full
analysis sample (FAS) and per protocol sample (PPS) for all
measures of efficacy. In the PPS, the pregnancy rates at 12 weeks
gestation were 37.6 percent and 33.1 percent in the oral
dydrogesterone and MVP treatment groups, respectively,
demonstrating non-inferiority of oral dydrogesterone to MVP8. For
the secondary objectives, the Lotus I study demonstrated that
pregnancy rate two weeks after embryo transfer and at eight weeks
of gestation as well as live birth rates were similar for both
treatments.
About the Study
Lotus I was a double-blind,
double-dummy, two arm multicenter, international Phase III
randomized controlled study conducted across 38 sites in
Austria, Belgium, Germany, Finland, Israel, Russia and Spain. The study took place from August 2013 to March
2016 and was performed in accordance with the Declaration of
Helsinki and Good Clinical
Practice guidelines.
The study enrolled pre-menopausal women undergoing IVF treatment
(>18 to <42 years of age with a documented history of
infertility who were planning to undergo IVF).
Lotus I participants were randomized to receive either oral
dydrogesterone 10 mg or MVP 200 mg three times daily. This
treatment to prepare the lining of the uterus (luteal support) was
started on the day of oocyte retrieval (egg collection) and
continued for up to 12 weeks of gestation.
About Dydrogesterone
Dydrogesterone has been marketed
for more than 50 years for conditions related to progesterone
insufficiency. The safety and tolerability profile of the drug has
been established with an estimated exposure to 94 million patients
globally9, 10.
The use of dydrogesterone is specific to the regulatory approval
in each country and includes the treatment of threatened or
recurrent miscarriage, as well as luteal phase support in
infertility and menstrual disorders, endometriosis and hormone
replacement therapy post menopause. The use of dydrogesterone in
pregnancy is not indicated in all countries.
Currently, dydrogesterone is not approved in any country for the
treatment of luteal phase support in IVF or artificial reproductive
technology.
About Abbott
At Abbott (NYSE: ABT), we're committed to
helping you live your best possible life through the power of
health. For more than 125 years, we've brought new products and
technologies to the world -- in nutrition, diagnostics, medical
devices and branded generic pharmaceuticals -- that create more
possibilities for more people at all stages of life. Today, 94,000
of us are working to help people live not just longer, but better,
in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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1
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Dyer S, Chambers GM,
de Mouzon J, Nygren KG, Zegers-Hochschild F, Mansour R, Ishihara O,
Banker M, Adamson GD. International Committee for Monitoring
Assisted Reproductive Technologies world report: Assisted
Reproductive Technology 2008, 2009 and 2010. Hum Reprod
2016;31:1588–1609.
|
2
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Chambers GM, Hoang
VP, Zhu R, Illingworth PJ. A reduction in public funding for
fertility treatment – an econometric analysis of access to
treatment and savings to government. BMC Health Services Research
2012; 12:142
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3
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Mesen TB and Young
SL. Progesterone and the Luteal Phase. Obstetrics and
Gynecology Clinics of North America.
2015;42(1):135-151.
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4
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'Factsheet - In vitro
fertilization (IVF): what are the risks?' The Patient Education
Website of the American Society for Reproductive Medicine
http://www.reproductivefacts.org/uploadedFiles/ASRM_Content/Resources/Patient_Resources/Fact_Sheets_and_Info_Booklets/risksofivf.pdf
[Accessed 7 February 2017]
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5
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'Factsheet:
Progesterone Supplementation During In Vitro Fertilization (IVF)
Cycles' The Patient Education Website of the American Society for
Reproductive Medicine
http://www.reproductivefacts.org/FACTSHEET_Progesterone_Supplementation_During_IVF_Cycles/
[Accessed 7 February 2017]
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6
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Chakravarty BN,
Shirazee HH, Dam P, et al. Oral dydrogesterone versus intravaginal
micronised progesterone as luteal phase support in assisted
reproductive technology (ART) cycles: results of a randomised
study. J Steroid Biochem Mol Biol
2005;97(5):416–420
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7
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Vaisbuch E, Leong M,
Shoham Z. Progesterone support in IVF: is evidence-based medicine
translated to clinical practice? A worldwide web-based survey.
Reprod Biomed Online 2012;25:139–145.
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8
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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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9
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Queisser-Luft A.
Dydrogesterone use during pregnancy: overview of birth defects
reported since 1977. Early Hum Dev
2009;85(6):375‒377
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10
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Mirza FG, Patki A,
Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol
Endocrinol 2016;32(2):97‒106
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SOURCE Abbott