Ultra-low-dose vaginal estrogen tablets for the treatment of postmenopausal vaginal atrophy

ABSTRACT

Vaginal atrophy is a common chronic condition affecting up to 57% of postmenopausal women. The decrease in estrogen following cessation of menses can lead to bothersome symptoms that include vaginal dryness and irritation, pain and burning during urination (dysuria), urinary tract infections, and pain (dyspareunia) and bleeding during sexual activities. These symptoms can be safely and effectively managed with the use of local estrogen therapy, which reduces the risks associated with long-term systemic hormone therapy. The ultra-low-dose 10 μg estradiol vaginal tablet is the lowest approved dose available and has an annual estradiol exposure of only 1.14 mg. Its development addresses recommendations from regulatory agencies and women's health societies regarding the use of the lowest hormonal dose. The 10 μg vaginal tablet displays minimal estradiol absorption, causes no increased risk of endometrial hyperplasia or carcinoma, and provides significant symptom relief. The clinical evidence presented here may offer greater reassurance to health-care professionals and postmenopausal women that vaginal atrophy can be treated safely and effectively.

Key words::

• VAGINAL ATROPHY
• VAGINAL TABLET
• ESTRADIOL
• POSTMENOPAUSAL WOMEN

Conflict of interest Dr J. A. Simon has served (within the last year) or is currently serving as a consultant to or on the advisory boards of: Abbott Laboratories (Abbott Park, IL), Agile Therapeutics, Inc. (Princeton, NJ), Amgen Inc. (Thousand Oaks, CA), Ascend Therapeutics (Herndon, VA), BioSante (Lincolnshire, IL), Depomed, Inc. (Menlo Park, CA), Intimina by Lelo, Inc. (San Jose. CA), MD Therapeutics (Boca Raton, FL), Meda Pharmaceuticals Inc. (Somerset, NJ), Merck (Whitehouse Station, NJ), Novo Nordisk (Bagsværd, Denmark), Novogyne (East Hanover, NJ), Pfizer Inc. (New York, NY), Shionogi Inc. (Florham Park, NJ), Shippan Point Advisors LLC (Upper Saddle River, NJ), Slate Pharmaceuticals Inc. (Durham, NC), Sprout Pharmaceuticals (Raleigh, NC), Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), Warner Chilcott (Rockaway, NJ), and Watson Pharmaceutical Inc. (Corona, CA). In the last year he has received or is currently receiving grant/research support from: BioSante (Lincolnshire, IL), EndoCeutics Inc. (Quebec, Quebec), Novo Nordisk (Bagsværd, Denmark), Novogyne (East Hanover, NJ), Palatin Technologies (Cranbury, NJ), Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), and Warner Chilcott (Rockaway, NJ). He has also served or is currently serving on the speakers’ bureaus of: Amgen Inc. (Thousand Oaks, CA), Merck (Whitehouse Station, NJ), Novartis (Basel, Switzerland), Novo Nordisk (Bagsværd, Denmark), Novogyne (East Hanover, NJ), Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), and Warner Chilcott (Rockaway, NJ). Dr Simon is currently the Chief Medical Officer for Sprout Pharmaceuticals (Raleigh, NC). Dr. R. V. Maamari is an employee of Novo Nordisk.

Source of funding Editorial assistance was provided by Katherine Yam, PhD, ETHOS Health Communications, Newtown, Pennsylvania, with financial assistance from Novo Nordisk Inc, Princeton, New Jersey, in compliance with international guidelines on Good Publication Practice. The authors received no remuneration of any kind for the development of this manuscript.