EstroGel®: First Transdermal Estrogen Gel Available
(Marietta, GA, July 27, 2004): Solvay Pharmaceuticals, Inc. today announced
that EstroGel® (estradiol gel), the first transdermal estrogen gel
in the country, is now available with a prescription to treat moderate to severe
hot flashes and moderate to severe dryness, itching, and burning in and around
the vagina. If using to only treat vaginal symptoms, topical vaginal products
should be considered.
Approved by the US Food and Drug Administration (FDA) on Feb. 9, 2004, EstroGel®
is a clear, colorless, hydro-alcoholic gel that provides continuous delivery
of estradiol through the skin in a non-patch transdermal form. Applied once
daily on one arm from wrist to shoulder, EstroGel® has a low incidence
of application site reactions. After application, the gel dries in as little
as two to five minutes and is odorless.
"As a healthcare provider, I am excited about this new, transdermal delivery
option for my patients that is clean and discreet," said Dr. Alan Altman, menopause
specialist, gynecologist and Harvard professor. "Healthcare providers now have
an additional hormone therapy treatment option, which will allow them to individualize
therapy for their patients - specifically tailoring therapy to a woman's symptoms,
medical history and delivery preference," Altman added.
The only FDA approved estrogen therapy available in gel form, EstroGel®
is also a prescribed in Europe. Absorbed directly into the bloodstream, the
transdermal delivery of EstroGel® ensures the body receives a consistent
and continuous supply of estrogen throughout the day.
"We are extremely pleased to bring EstroGel® to market at a
time when women are interested in alternative delivery options for estrogen
therapy," said Harold H. Shlevin, Ph.D., president and CEO of Solvay Pharmaceuticals,
Inc. "This new estrogen delivery vehicle demonstrates Solvay Pharmaceuticals'
commitment to providing safe, effective treatments for hormone therapy."
EstroGel® joins the portfolio of Solvay Pharmaceuticals Women's
Health products - PROMETRIUM®, ESTRATEST® and ESTRATEST
EstroGel® will be prescribed at a 1.25g daily dose; each pump delivers
64 doses. EstroGel® is packaged in a non-aerosol, metered-dose pump
that delivers one dose of gel per compression.
Data supporting the efficacy and tolerability of EstroGel® in reducing
the frequency and severity of moderate-to-severe vasomotor symptoms was demonstrated
in a 12-week, double-blind, randomized, placebo-controlled, multicenter study.
The study analyzed the effects of EstroGel® on 145 healthy, postmenopausal
women suffering from moderate-to-severe hot flashes.
Patients should not use EstroGel® if they have unusual vaginal
bleeding, currently have or have had certain cancers (including breast and cancer
of the uterus), have had a stroke or heart attack in the last year, currently
have or have had blood clots (e.g., in the legs), currently have or have had
liver problems, are allergic to EstroGel® or any of its ingredients,
are or may be pregnant or are breast feeding.
Estrogens with or without progestins should not be used to prevent heart
attacks or heart disease. In clinical studies, estrogens given in
combination with progestins have been reported to increase the risk of heart
attacks, stroke, breast cancer, blood clots in menopausal women. Because of
these risks, the lowest dose that relieves symptoms should be used for the shortest
Close monitoring of all women taking estrogens is important. Estrogens
increase the chances of getting cancer of the uterus. Please see your healthcare
professional if you are taking an estrogen and have continued or intermittent
EstroGel® should be used in combination with a progestin in women
with an intact uterus. There is no evidence to support that "natural" estrogens
are safer than synthetic derived estrogens with regard to risks for endometrial
cancer (lining of the uterus).
The commonly reported side effects are those typical of estrogen therapy:
headache, breast pain, irregular vaginal bleeding or spotting, stomach cramps/bloating,
nausea and vomiting, and hair loss.
For complete safety and prescribing information, click
For more information on menopause, click here.
Estrogel is sold by Solvay Pharmaceuticals, which has provided an educational
grant to provide partial support DrDonnica.com.
Created: 8/9/2004  - Donnica Moore, M.D.