Navigation Links
New Subset Analysis of AndroGel(R) Data Highlights Efficacy - Regardless of BMI
Date:6/17/2008

MARIETTA, Ga., June 17 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced today that a new analysis of pivotal study data conducted by the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center showed that initial treatment response of hypogonadal men with AndroGel(R) (testosterone gel) 1% CIII had similar effects on subjects, regardless of weight and body mass index (BMI). These study results were presented today at the 2008 Endocrine Society Annual Meeting (ENDO) in San Francisco.

"Multiple studies have shown that obese men are at an increased risk of having low testosterone levels, so these new findings provide important insight into optimal treatment regimens for hypogonadal men," said Dr. Christina Wang, a study investigator at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. "However, despite the growing body of evidence surrounding the benefits of testosterone therapy for those who are hypogonadal, men are often unaware that the symptoms they are experiencing can be attributed to low testosterone and, therefore, are left undiagnosed and untreated."

The analysis presented is based on a new subset evaluation of a six-month safety and efficacy study of AndroGel published in 2000, from which researchers originally concluded that AndroGel was effective in restoring testosterone levels and in some cases, superior to a transdermal testosterone patch. In 2004, an additional follow-up, 36-month, open-label extension study was published that showed that AndroGel was safe for men to use over the long term.

Study Highlights

The study presented at ENDO examined the relationship between BMI and sex hormones in hypogonadal men both before and after treatment with testosterone. The study found:
-- Neither testosterone nor free testosterone is significantly related to

BMI either before or after testosterone treatment.

-- Testosterone treatment decreases SHBG more in lean men than in obese

men, suggesting that SHBG is more influenced by the serum E2 and

E2/testosterone ratio than testosterone levels.

-- Interactions of obesity, sex hormone-binding globulin (SHBG) and serum

testosterone in men with low testosterone are complex both at baseline

and after testosterone treatment.

"We are pleased that the AndroGel pivotal data continue to aid physicians and researchers in helping to treat men suffering from the symptoms associated with low testosterone, as we learn more everyday about the appropriate treatments for this patient population," said Dr. Stephen Hill, president and chief executive officer, Solvay Pharmaceuticals, Inc.

About Low Testosterone

It is estimated that hypogonadism, also known as low testosterone, affects more than 13 million men in the United States age 45 and older. Because signs and symptoms of low testosterone are subtle and often overlap with other common medical conditions, low testosterone is frequently undiagnosed. Signs and symptoms of low testosterone include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density.

Men with chronic conditions, such as obesity, diabetes, high blood pressure, high cholesterol and asthma/COPD, are also more likely to have low testosterone compared to other men. Below normal levels of testosterone can be confirmed by a blood test. Testosterone treatment is designed to elevate a hypogonadal male's testosterone levels into the normal physiologic range, which may alleviate symptoms related to low testosterone. As with any medication, patients should work with their physician to weigh treatment benefits and risks.

About AndroGel(R)

AndroGel, the first U.S. Food and Drug Administration (FDA)-approved testosterone gel available in a non-aerosol, metered-dose pump, is a once- daily, clear, odorless topical testosterone gel approved in 2000 for replacement therapy in men ages 18 and older for conditions associated with a deficiency or absence of endogenous testosterone. AndroGel is the most prescribed form of testosterone therapy for adult males in the United States.

Pivotal data showed that AndroGel was effective in restoring testosterone levels to normal and in some cases, superior to a transdermal testosterone patch.

-- AndroGel was effective in improving sexual function, mood, and muscle

strength; increasing lean body mass; and decreasing body fat.

-- It was demonstrated that AndroGel was more effective than a

testosterone patch in increasing lean body mass and decreasing body

fat, and had comparable effects with other symptoms.

-- Because of minimal skin irritation, subjects using AndroGel also had

higher compliance rates.

-- In a 2004 open-label, follow-up extension study, AndroGel was shown to

be safe for men to use over the long term.

The AndroGel pump is designed to deliver 1.25 grams of testosterone gel per pump depression, and it is also available in 2.5 and 5 gram packets. This gives patients two convenient ways to use AndroGel and offers physicians added flexibility to move, if necessary, from the starting dose of 5g per day to 7.5g or from 7.5g to 10g per day.

AndroGel must not be used if you have known or suspected prostate cancer or breast cancer (a rare condition for men). AndroGel must not be used by women who are pregnant, may become pregnant, or breastfeeding, as testosterone may cause fetal harm. The major risks of AndroGel include prostate enlargement, prostate cancer, and transfer of testosterone to others (including women and children). Transference can occur when vigorous skin-to- skin contact is made with the application site and can be minimized by washing your hands after application and covering the application site with clothing.

The most common adverse events reported are skin irritation where gel is applied, breast development or tenderness, acne, prostate enlargement, changes in lab test results, and changes in urinary habits.

Remember, this information does not take the place of the advice you get from your doctor or other health care professional. Always talk with your doctor if you have questions about AndroGel.

Unimed Pharmaceuticals, LLC., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., holds the exclusive rights to AndroGel in the United States.

About Solvay Pharmaceuticals, Inc.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit http://www.solvaypharmaceuticals-us.com.

Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2007 sales were EUR 2.6 billion and it employs more than 9,000 people worldwide. For more information, visit http://www.solvaypharmaceuticals.com.

SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to EUR 9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at http://www.solvay.com.


'/>"/>
SOURCE Solvay Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. GeneGo is Awarded NCI Grant for Development of Systems Biology Platform for Integrative Data Analysis in Cancer
2. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
3. New Meta-Analysis Confirms Safety Profile for NeoRecormon in Treating Anaemia in Cancer Patients
4. Abbotts Phase III Sub-Group Analysis Shows Investigational TriLipix(TM) in Combination with CRESTOR(R) Improves Key Lipids in Patients with Mixed Dyslipidemia and Type 2 Diabetes
5. New Analysis Shows Efficacy of REMICADE(R) in Treatment of Ulcerative Colitis in Patients with Recent Disease Onset or Long-Standing Disease
6. Analysis of Ulcerative Colitis (UC) Time to Symptom Resolution Data from Pivotal Study of LIALDA(TM) (mesalamine) Presented at DDW
7. New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months
8. Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
9. AlphaVax Announces Initial Analysis of Data From CMV Phase 1 Clinical Trial
10. Prospective Microbial Analysis of Bronchoalveolar Lavage Fluids with Immune Function Testing Can Distinguish Between Fungal Colonization and Fungal Disease In Lung Transplant Recipients
11. Favrille Announces Data Cutoff for Phase 3 Registration Trial of Specifid; Data Analysis and Unblinding Expected in June
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)...  As the latest Obamacare repeal effort moves is ... (R-LA) and Lindsey Graham (R-SC) medical device ... industry is in an odd place.  The industry wants ... tax on medical device sales passed along with the ... increased visits and hospital customers with the funding to ...
(Date:9/19/2017)... --  ZirMed Inc ., a recognized leader in cloud-based revenue ... been ranked #1 by its users for the seventh consecutive ... Survey. ZirMed was recognized as the top-ranked end-to-end revenue cycle ... over 200 beds and holds one of the longest #1 ... ...
(Date:9/13/2017)... 13, 2017   OrthoAtlanta has been named the ... Host Committee (AFHC) for the 2018 College Football Playoff (CFP) ... at Mercedes-Benz Stadium in Atlanta, Georgia . ... "I,m In" campaign, participating in many activities leading up to, ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Dickinson Insurance and Financial ... financial preparation services, is providing an update on a charitable event that began ... Rescue is a locally recognized nonprofit that provides shelter and care for animals ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and ... Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD ... that can be easily incorporated into liquid products, while reducing costs to end users. ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The Visiting ... Day Market. Featuring a collection of specialty vendors and unique items from across the ... and quality-focused health and wellness services offered by the VNA. The boutique will ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
Breaking Medicine News(10 mins):