Navigation Links
New Data Reveal Topical Divigel(R) (estradiol gel) 0.1% Significantly Reduces Frequency and Severity of Hot Flashes
Date:10/3/2007

Lowest Dose of Estradiol Shown to Be Safe and Effective for Menopausal

Women

WEST PALM BEACH, Fla., Oct. 3 /PRNewswire/ -- A study presented today at the 2007 Annual Meeting of the North American Menopause Society (NAMS) revealed that Divigel(R) (estradiol gel) 0.1% significantly reduced the frequency and severity of moderate to severe hot flashes associated with menopause. Additional data presented at the meeting found that Divigel(R) is a safe and well-tolerated therapy offering the lowest approved dose of estradiol available for the treatment of hot flashes, the most common symptom of menopause.

"These data demonstrate that Divigel(R) is a safe and highly effective low dose therapy that quickly manages the uncomfortable side effects of menopause," said Dr. Ronald Ackerman, FACOG, CEO and principal investigator, Comprehensive Clinical Trials. "Women that have been reluctant to take older hormone therapies with higher doses of estrogen now have the choice of taking Divigel(R), the lowest dose of estradiol available."

Guidelines from the North American Menopause Society (NAMS) indicate that estrogen hormone therapy should be used at the lowest effective dose for the shortest amount of time.

"Divigel(R) is applied to the skin where it absorbs directly into the bloodstream without having to pass through the liver. This provides treatment continuity allowing women to use less estrogen than is needed in a pill because of the way the therapy is delivered," said Dr. Ackerman. "Transdermal therapies have been used in Europe for years, and they are becoming increasingly common in the United States. The availability of this lowest dose estrogen gel combined with its convenience makes Divigel(R) a valuable option for physicians and patients."

This 12-week study evaluated 488 postmenopausal women presenting with moderate to severe vasomotor symptoms. The study compared placebo to Divigel(R) at doses of 1.0 g gel/day, 0.5 g gel/day and 0.25 g gel/day. Approximately 120 patients were randomized to each treatment group. Study endpoints included mean change from baseline in daily frequency and severity of moderate to severe hot flashes.

Consistent with FDA requirements, both the Divigel(R) 0.5 g and 1.0 g treatment groups demonstrated a statistically significant reduction in the frequency and severity of vasomotor symptoms by week four. The Divigel(R) 0.25 g group demonstrated a statistically significant reduction in the frequency and severity of vasomotor symptoms by week seven. Statistically significant differences were maintained through the duration of treatment (12 weeks). Divigel(R) also had an excellent tolerability profile and less than one percent of patients experienced skin irritation reactions at the treatment application site.

Divigel(R) was approved by the U.S. Food and Drug Administration (FDA) in June 2007. The estrogen in Divigel(R) is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause. Divigel(R) is a quick-drying gel that is odorless when dry, and is available in convenient, individual-use packets. One packet of gel is applied daily to an area that measures approximately 5 x 7 inches on the thigh, the smallest application area compared to all other available gel or lotion estrogen products. Divigel(R) also offers dosing flexibility with three different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and 1.0 mg estradiol/day) to individualize treatment for each woman.

For more information, call 1-800-654-2299 or visit http://www.divigelus.com.


'/>"/>
SOURCE Comprehensive Clinical Trials
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Largest National U.S. Healthcare Facility MRSA Study Reveals Infection Rates Eight Times Greater Than Previous Estimates
2. Neurocrine Biosciences Announces New Research Studies Presented at APSS Reveal Significant Under-Diagnosis of Insomnia
3. Waismann Method Survey Reveals Dependency Risk for People Using Suboxone
4. New Study Reveals Limitations of a Complex and Challenging Global Tuberculosis Drug Marketplace
5. Waismann Method Survey Reveals 65 Percent of Women Seeking Opiate Dependency Treatment Are Mothers
6. Newly Published Study Reveals Femara Improves Chances for Harder to Treat Early Breast Cancer Relapse in Postmenopausal Women
7. Targeting Specific Mutations Reveals Promising New Approach to Treating Genetic Disorders; Preclinical Data Published in Nature
8. First-of-its-Kind National Report Reveals Estimated High Prevalence and Heavy Cost of Type 2 Diabetes Complications in America
9. Over 10,000 UK Breast Cancer Patients Could Become Eligible Within the Next Year for a Breast Cancer Therapy Showing Increased Survival Rates, Reveals Synovate Healthcare’s European Oncology Monitor
10. Survey Reveals Significant Public Lack of Diabetes Awareness
11. Medical Journal Publishes First Large-Scale Survey Revealing Experiences of IPF Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... SPRINGS, Florida , May 25, 2016 ... Business Conference & Expo earlier this month, the numbers ... As revenues continue to climb into the billions, more ... the newly released 4th Edition State of Legal Marijuana ... Frontier, a cannabis-focused data-analysis firm, much of the increase ...
(Date:5/25/2016)... , May 25, 2016 Digital Health ... to it by the US Patent and Trademark ... technology includes proprietary processes for electronic opt-­in and ... and wellness programs, HIPAA compliance and otherwise. ... "Our technology allows for ...
(Date:5/25/2016)... , May 25, 2016 ... the precision of circulating tumour DNA (ctDNA) analysis ... the appointment of Professor Clive Morris ... leadership across the clinical development programme, scientific collaborations, ... help deliver significant improvements in clinical outcomes for ...
Breaking Medicine Technology:
(Date:5/28/2016)... ... 28, 2016 , ... May 26, 2016- In search of the K. Warriors, ... event of “K Warriors” on June 4, 2016 at Ashbury Hotel and Suites 600 ... sponsored and hosted by Shaolin Institute and sanctioned by KSF (Kungfu Sanda Federation), This ...
(Date:5/28/2016)... , ... May 28, 2016 , ... In a part of the city where’s it’s ... new farm-to-table Kelowna restaurants is hoping to attract diners with a taste for ... Suites officially opened the doors to Cornerstone Grill, an urban casual restaurant focusing on ...
(Date:5/27/2016)... ... May 27, 2016 , ... Southland Log Homes , designer ... timber frame barn kits, which can be found on its website at SouthlandLogHomes.com. , ... barn plans, and they highlight the craftsmanship of timber post and beam construction. ...
(Date:5/27/2016)... ... May 27, 2016 , ... W.S. Badger Co. ... today that it has been recognized as one of the best small businesses for ... named as one of nine small businesses providing progressive benefits to new parents on ...
(Date:5/27/2016)... ... May 27, 2016 , ... With over 60 percent ... the demand for a sustainable product to aid in the rehabilitation process has steadily ... the recovery of individuals with hemiplegia due to stroke. , Ekso Bionics has now ...
Breaking Medicine News(10 mins):