Company: Unimed Pharmaceuticals Approval Status: Approved February 2000 Treatment for: For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone Areas: Diabetes / Endocrinology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
AndroGel is a hydroalcoholic gel to be applied to the clean, dry skin of the shoulders, upper arms and/or abdomen. The gel is absorbed through the skin and delivers testosterone to the patient for approximately 24 hours. This product is indicated for men with primary hypogonadism or hypogonadotropic hypogonadism which results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations.
Two types of hypogonadism for which this drug is indicated: 1. Primary hypogonadism: testicular failure; characterized by low serum testosterone levels and gonadotropins (FSH, LH) above the normal range
2. Hypogonadotropic hypogonadism: idiopathic gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation; characterized by low serum testosterone levels, but with gonadotropins in the normal or low range
In addition to supplying sufficient amounts of testosterone, AndroGel, like other drugs in its class, may promote retention of nitrogen, sodium, potassium, phosphorus, and decreased urinary excretion of calcium. Furthermore, it may increase protein anabolism and decrease protein catabolism. This class of drugs (androgens) may also stimulate the production of red blood cells.
Hypogonadism affects approximately 4 to 5 million American men.
Symptoms of hypogonadism include:
227 hypogonadal men participated in a research study investigating AndroGel 1%. The study was conducted in 2 phases: an Initial Treatment Period of the first 90 days and an Extended Treatment Period of the second 90 days. During both treatment stages, patients were randomized into different AndroGel dose groups and one non-scrotal testosterone transdermal system group. The first phase investigated 5 G daily and 10 daily of AndroGel and 5 mg daily of non-scrotal testosterone transdermal system. In the extended treatment phase, groups of patients continued with either 5 G daily or 10 G daily of AndroGel or 5 mg daily of non-scrotal testosterone transdermal system, and an additional treatment group taking 7.5 G AndroGel daily was added.
Results of the study showed that serum testosterone concentrations increased to the normal range within first day of treatment with doses of 5 G and 10 G. In patients continuing on AndroGel 5 G and 10 G, these mean testosterone levels were maintained within the normal range for the 180-day duration of the study. 87% of patients whose data could be analyzed achieved normal serum testosterone level on treatment day 180.
5 G, 7.5 G and 10 G doses of AndroGel all also significantly increased total body mass and total body lean mass and decreased total body fat mass and percent body fat. Furthermore, with 10 G AndroGel bone mineral density in the hip and spine increased significantly.
As a result of all doses of AndroGel, patients showed significant increases in libido and degree of penile erection and significant positive effects on mood and fatigue.
Another research study was conducted in order to investigate whether AndroGel could be transferred through skin-to-skin contact. AndroGel patients and their female partners engaged in daily vigorous skin-to-skin sessions. When evaluated, all unprotected females showed testosterone levels >2 times the baseline value at some point during the study. Wearing clothing, on the other hand, during skin-to-skin contact, prevented any transfer of the drug.
The following adverse effects were possibly, probably or definitely related to the use of AndroGel and reported by >1% of the patients:
*Denotes side effect reported in long-term follow-up study **Denotes side effect also reported in the initial clinical studies and long-term follow-up study
Precautions:
This product is contraindicated in men with carcinoma of the breast or prostate.
Do not apply AndroGel to the genitals.
Women should not use this product.
Pregnant women should have no contact with this product, as it may cause fetal harm.
This product has not been tested for men under 18 years of age.
AndroGel is a hydroalcoholic formulation that dries quickly when applied to the skin surface. The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation
Circulating testosterone is chiefly bound in the serum to sex hormone-binding globulin (SHBG) and albumin. The albumin-bound fraction of testosterone easily dissociates from albumin and is presumed to be bioactive. The portion of testosterone bound to SHBG is not considered biologically active. The amount of SHBG in the serum and the total testosterone level will determine the distribution of bioactive and nonbioactive androgen. SHBG-binding capacity is high in prepubertal children, declines during puberty and adulthood, and increases again during the later decades of life. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins...(From FDA Label)
Visit the Unimed Pharmaceuticals, Inc. web site, http://www.unimed.com, to learn more about AndroGel and about other products, research, and services provided by the company that developed this drug.
For more information about hypogonadism, visit http://www.hypogonadism.com.
The Androgel Testosterone Gel drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
Continued here:
AndroGel testosterone gel - Drug information from MediLexicon
Contact Us Today For A Free Consultation
- Testosterone gel - Drugs dot com - April 12th, 2021
- Testosterone cream and gel for supplementation treating hypogonadism - March 13th, 2021
- Testosterone Gel Information - September 9th, 2020
- Testosterone Creams for Low Testosterone Treatment and Andropause - August 10th, 2020
- What Causes Dark Circles Under Your Eyes? - May 16th, 2020
- Testosterone Replacement Beneficial for Modern Men? - February 11th, 2020
- Tefina nasal gel claims to boost number of orgasms a woman can have - June 18th, 2019
- LowTestosterone.com - Testosterone Gel - August 11th, 2016
- Side Effects of Testim (Testosterone Gel) Drug Center - RxList - May 5th, 2016
- DailyMed - TESTIM - testosterone gel - May 3rd, 2016
- Testosterone gel is no fountain of youth, study finds - CBS News - April 10th, 2016
- DailyMed - TESTOSTERONE- testosterone gel - February 8th, 2016
- Testosterone Gel & Testicular Shrinkage! - October 24th, 2015
- Testim (Testosterone Gel) Drug Information: Medication ... - October 24th, 2015
- Low Thyroid Level Symptoms | HagglundMD.com Thyroid Doctor - September 26th, 2015
- List Of Low-Carb Doctors - September 25th, 2015
- AndroGel (testosterone gel) - August 12th, 2015
- AndroGel® (Testosterone Gel) 1.62% - August 2nd, 2015
- Testim gel: Indications, Side Effects, Warnings - Drugs.com - July 3rd, 2015
- Testim (Testosterone Gel) Drug Information: Description ... - July 3rd, 2015
- DailyMed - TESTOSTERONE- testosterone gel, metered - July 3rd, 2015
- Testosterone Gel Treatment of Gynecomastia | eHow - April 6th, 2015
- Why Repros Therapeutics, Inc. Shares Are Soaring - April 2nd, 2015
- Low T Treatment | FORTESTA (testosterone) Gel CIII - March 17th, 2015
- Testosterone Gel - How RS Transaderm makes your test ... - March 12th, 2015
- MEDICATION GUIDE Testosterone (tes-TOS-te-rn) Gel, CIII - March 12th, 2015
- High testosterone ups heart disease risk in men - March 10th, 2015
- Men's heart disease risk linked to high testosterone and low estrogen - March 9th, 2015
- Higher heart disease risk for men due to high testosterone, low estrogen - March 9th, 2015
- Vital Health, Inc. Provides Tips On How To Combat Cystic Acne Through Dietary Changes and Natural Remedies - February 20th, 2015
- Men, women: Why cholesterol matters - January 30th, 2015
- Gilead rival AbbVie's new hepatitis C treatment wins EU approval - January 20th, 2015
- Testosterone Gel A Convenient, Natural Solution - December 30th, 2014
- Doctor's Testosterone Gel - Buy Doctors Testosterone Gel ... - December 28th, 2014
- DailyMed - ANDROGEL- testosterone gel - November 25th, 2014
- Endo Int'l Buys Rights To Natesto Testosterone Nasal Gel From Trimel BioPharma - November 25th, 2014
- Secaucus police officer charged with selling steroid gel on eBay: officials - November 18th, 2014
- What Are the Benefits of Testosterone Gel? | eHow - November 2nd, 2014
- AbbVie Sales Blow Past Expectations - October 31st, 2014
- Buy Cernos Gel, Buy Testosterone Gel from Certified Online ... - October 28th, 2014
- testosterone gel (Androgel): Drug Facts, Side Effects and ... - October 3rd, 2014
- Woman Says Dentists Testosterone Gel Rubbed Off On Her During Sexual Attack, Causing Her To Grow Unsightly Body Hair - September 30th, 2014
- Androxal superior to Androgel in Phase 3 trial - September 27th, 2014
- 'When I look at myself I am not impressed at all' - August 2nd, 2014
- Don't Make This Big Investing Mistake Once Interest Rates Start Rising - August 2nd, 2014
- Why Isn't This Swirling Low in the Atlantic a Tropical Storm? - August 2nd, 2014
- As Political Disenchantment Soars, Lines At The Polls Grow Shorter - July 26th, 2014
- Love Letters: We Don't Have Much To Talk About - July 26th, 2014
- Wonkblog: Britains economy is finally bigger than it was in 2008. What took so long? - July 26th, 2014
- Wounded veteran is standing tall, looking to the future - July 6th, 2014
- Testosterone Nasal Gel Claims To Help Women Reach Orgasm (And Has 'No Side Effects') - June 18th, 2014
- Book Extract: Set ambitious targets to win - June 2nd, 2014
- Double Blessing For Trimel Pharma... - May 31st, 2014
- Testosterone Gels - May 1st, 2014
- Andractim Testosterone Gel for Testosterone Replacement ... - April 30th, 2014
- AUXL Gives Bleak Outlook, IG Reverses Loss, ENDP Opens Wallet, BOTA Stops Work - April 30th, 2014
- How to Apply Testosterone Gel - 31 Day Testosterone Plan - Video - April 22nd, 2014
- Is Your Husband At Risk for a Testosterone Heart Attack? - April 16th, 2014
- Testosterone Cypionate | Best Testosterone Supplments - April 14th, 2014
- Low T Litigation - Video - April 2nd, 2014
- Perrigo sues FDA over failure to grant therapeutic equivalence rating for testosterone gel - March 24th, 2014
- Testosterone Monograph for Professionals - Drugs.com - March 7th, 2014
- Could the male hormone testosterone transform a woman's looks, life and libido? - March 6th, 2014
- Group wants heart attack warning on testosterone - Quincy Herald-Whig | Illinois & Missouri News, Sports - February 25th, 2014
- Startling Effects of Testosterone Therapy - February 8th, 2014
- Questions & Answers 195 - Video - February 5th, 2014
- Testosterone Tx Ups Heart Attack Risk at Any Age - January 31st, 2014
- Testosterone Treatments Linked to Heart Attacks - January 30th, 2014
- Testosterone gel: Indications, Side Effects, Warnings ... - January 23rd, 2014
- Testosterone Gel Vs. Patch | eHow - eHow | How to Videos ... - December 24th, 2013
- AndroGel (Testosterone Gel for Topical Use) Drug Information ... - December 24th, 2013
- Female Sexual Desire Drug Rejected by U.S. Regulators - December 12th, 2013
- Manufacturers of "female Viagra" appeal FDA denial - December 12th, 2013
- Side Effects of AndroGel (Testosterone Gel for Topical Use ... - December 10th, 2013
- Testosterone Gel Treatment | eHow - eHow | How to Videos ... - December 6th, 2013
- Testosterone Gels | Do They Work? - December 5th, 2013
- Testosterone skin gel: Information from Answers.com - November 28th, 2013
- AndroGel testosterone gel New FDA Drug Approval | CenterWatch - November 23rd, 2013
- What is Testosterone Gel? | Consumer Health PanelConsumer ... - November 18th, 2013
- What is Testosterone Gel? | Consumer Health PanelConsumer Health Panel - November 15th, 2013
Word Count: 854