Estradiol vaginal inserts (4 µg and 10 µg) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data

Current Medical Research and Opinion
Ginger ConstantineSebastian Mirkin

Abstract

To review safety, efficacy and pharmacokinetic (PK) data from the phase 3 REJOICE trial, which evaluated a 17β-estradiol (E2) softgel vaginal insert approved in 2018 for moderate to severe dyspareunia associated with menopausal vulvar and vaginal atrophy (VVA). REJOICE (Clinicaltrials.gov: NCT02253173) was a randomized, double-blind, placebo-controlled trial in which women with moderate to severe dyspareunia due to menopausal VVA received 4 µg, 10 µg or 25 µg of an E2 vaginal insert or placebo for 12 weeks. The published data for the recently approved 4 µg and 10 µg doses of the E2 vaginal insert, including four co-primary efficacy endpoints (change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH and severity of dyspareunia), safety and PK (which included serum E2 levels measured by gas chromatography and tandem mass spectrometry), are summarized here. Women were randomized to receive the E2 vaginal insert (4 µg [n = 186] or 10 µg [n = 188]; Imvexxy a ) or placebo (n = 187) in the modified intention-to-treat population. The E2 vaginal insert (4 µg and 10 µg) significantly improved the percentages of superficial and parabasal cells (p < .0001), vaginal pH (p < .0001), and the severity score...Continue Reading

References

Jun 6, 2009·The Journal of Sexual Medicine·Nanette Santoro, Janne Komi
Jan 1, 2010·Mayo Clinic Proceedings·Maire B Mac BrideLynne T Shuster
Apr 29, 2010·Climacteric : the Journal of the International Menopause Society·M Eugster-HausmannD Lehnick
Sep 11, 2010·Maturitas·Rossella E Nappi, Marta Kokot-Kierepa
Oct 11, 2011·Menopause : the Journal of the North American Menopause Society·Margery L S GassDavid H Barad
Dec 16, 2011·Climacteric : the Journal of the International Menopause Society·R E Nappi, M Kokot-Kierepa
Apr 11, 2013·Menopause : the Journal of the North American Menopause Society·James A SimonRossella E Nappi
Aug 30, 2013·Menopause : the Journal of the North American Menopause Society
Nov 20, 2015·Climacteric : the Journal of the International Menopause Society·R E NappiM L Krychman
Jun 21, 2016·Climacteric : the Journal of the International Menopause Society·T J de VilliersD D Pierroz
Dec 7, 2016·Menopause : the Journal of the North American Menopause Society·Ginger D ConstantineUNKNOWN REJOICE Study Group
Dec 22, 2016·Menopause : the Journal of the North American Menopause Society·David F ArcherUNKNOWN REJOICE Study Group
Feb 15, 2017·Menopause : the Journal of the North American Menopause Society·Sheryl A KingsbergGinger D Constantine
Feb 17, 2017·The Journal of Sexual Medicine·Sheryl A KingsbergSebastian Mirkin
Jun 27, 2017·Menopause : the Journal of the North American Menopause Society·UNKNOWN The NAMS 2017 Hormone Therapy Position Statement Advisory Panel
Jun 13, 2018·Menopause : the Journal of the North American Menopause Society·JoAnn V PinkertonJoAnn E Manson

❮ Previous
Next ❯

Citations

Aug 28, 2020·Menopause : the Journal of the North American Menopause Society
May 14, 2021·Expert Opinion on Pharmacotherapy·Andrea R GenazzaniTommaso Simoncini
Aug 26, 2021·Human Reproduction Update·Andrea R GenazzaniTommaso Simoncini

❮ 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.