Pharmaceutical and clinical development of a novel progesterone formulation

Acta Obstetricia Et Gynecologica Scandinavica
Barbara Cometti

Abstract

Progesterone plays an essential role in reproductive events. Its use for luteal support in patients undergoing infertility treatment is an established practice. The different routes used to administer progesterone impact on its efficacy in luteal support: oral administration has been shown to be ineffective due to an extensive first-pass metabolism in the liver; vaginal application has a good efficacy but has drawbacks such as vaginal leakage, irritation, discomfort and uncertainty about the real dose adsorbed; finally, intramuscular administration ensures a precise dosage but can be extremely painful with, in some cases, formation of sterile abscesses. A new progesterone preparation is now available in several European and extra-European countries that combines the precise dosage of the injectable formulation with the comfort of a well-tolerated subcutaneous self-administration. The pharmacokinetic and pharmacodynamic properties of this new product are reviewed here, together with the clinical evidence obtained in two multicenter randomized clinical trials.

Associated Clinical Trials

References

Jun 1, 1991·Journal of in Vitro Fertilization and Embryo Transfer : IVF·J H CheckC Callan
Nov 1, 1988·American Journal of Obstetrics and Gynecology·E S ArafatR N Andersen
Sep 1, 1997·Obstetrics and Gynecology·R FanchinR Frydman
Nov 5, 1997·Annals of the New York Academy of Sciences·C BullettiC Flamigni
Dec 11, 1999·Fertility and Sterility·K JobanputraW E Gibbons
Feb 1, 2002·Fertility and Sterility·Alan S Penzias
May 16, 2002·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·A LewinA Safran
Nov 11, 2003·Fertility and Sterility·Jennifer L PhyMark A Damario
May 5, 2005·Current Opinion in Obstetrics & Gynecology·Recai Pabuccu, Munire Erman Akar
Oct 6, 2005·Archives of Pediatrics & Adolescent Medicine·Suzan L CarmichaelEdward J Lammer
Jul 13, 2007·Human Reproduction Update·H M FatemiP Devroey
Apr 15, 2008·Fertility and Sterility·Ziad R Hubayter, Suheil J Muasher
Apr 15, 2008·Fertility and Sterility·UNKNOWN Practice Committee of the American Society for Reproductive Medicine
Jun 4, 2008·Fertility and Sterility·Shai E Elizur, Togas Tulandi
Nov 26, 2008·Fertility and Sterility·UNKNOWN Practice Committee of American Society for Reproductive Medicine in collaboration with Society for Reproductive Endocrinolog
Jan 17, 2012·Fertility and Sterility·Lawrence Engmann, Claudio Benadiva
Nov 7, 2012·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Michael SatorGerhard Garhöfer
Mar 4, 2015·Seminars in Reproductive Medicine·Elena H Yanushpolsky

❮ Previous
Next ❯

Citations

Mar 17, 2018·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Roberta VenturellaFlippo M Ubaldi
Oct 9, 2019·Stress : the International Journal on the Biology of Stress·Cara M Hueston, Terrence Deak
Jul 1, 2020·PLoS Computational Biology·A Armean WrightMette S Olufsen
Apr 27, 2021·Current Opinion in Obstetrics & Gynecology·María Cerrillo MartínezElena Labarta Demur
May 20, 2021·Current Opinion in Obstetrics & Gynecology·María Cerrillo MartínezElena Labarta Demur

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.