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Testosterone in Medical Technology

Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations

... prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering ... and safety profile. Triptorelin decreased serum testosterone to the level of castration in all patients. Concurrent with the decrease in testosterone levels, the treatment reduced deviant sexual ...

Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations

... prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering ... and safety profile. Triptorelin decreased serum testosterone to the level of castration in all patients. Concurrent with the decrease in testosterone levels, the treatment reduced deviant sexual ...

Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy

... in combining the rapid, sustained suppression of testosterone that degarelix offers in this treatment. IADT ... levels of testosterone.(1)(2) Suppression of testosterone to castrate levels occurred significantly faster ... group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which ...

FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)

... intramuscular injection, an investigational testosterone preparation for the treatment of male ... NEBIDO is a novel, long-acting injectable testosterone preparation for the treatment of male ... NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing ...

Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men With Type 2 Diabetes and Metabolic Syndrome

... New Data Highlights the Need for testosterone Screening in At-Risk ... with Tostran(R), a topical, metered dose 2% testosterone gel, significantly improves insulin sensitivity ... regulatory authorities later this year. The testosterone replacement In hypogonadal men with either ...

New Subset Analysis of AndroGel(R) Data Highlights Efficacy - Regardless of BMI

... obese men are at an increased risk of having low testosterone levels, so these new findings provide ... body of evidence surrounding the benefits of testosterone therapy for those who are hypogonadal, men are ... they are experiencing can be attributed to low testosterone and, therefore, are left undiagnosed and ...

Research Explains How Advanced Prostate Cancer Becomes Resistant to Androgen-Deprivation Therapy

... Hutchinson Center. The researchers found that testosterone levels were four times higher in metastatic ... which disrupt the conversion of progesterone to testosterone precursors, as well as inhibitors of enzymes that perform subsequent steps in testosterone production: AKR1C3 and 17BHSD3. For the study, ...

Indevus Presents Successful Phase III NEBIDO(R) Data at American Urological Association

... 94 Percent of Men Maintained Normal testosterone Levels Throughout ... in the Phase III study had previously used other testosterone treatments. "An estimated four to five million ... of Urology at Harvard Medical School. "Low testosterone is associated with other significant health ...

Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)

... undecanoate), a long-acting injectable testosterone therapy under development for the treatment of ... demonstrated a rapid achievement of steady state testosterone levels, minimal excursions outside of the normal ... of patients maintaining a eugonadal (normal) testosterone range. NEBIDO met its primary endpoints, a ...

Testosterone May Improve Mental Function, From the Harvard Men's Health Watch

... mental processes. However, research suggests that testosterone levels may affect men's cognitive performance, ... cognitive impairment and dementia in others. testosterone levels decline with age, just when memory begins ... found some connections. For instance, higher testosterone levels in midlife have been linked to better ...

Indevus Announces Submission of New Drug Application

... intramuscular injection, a long-acting testosterone therapy intended to treat male patients with ... of NEBIDO in over 75 countries to date. The U.S. testosterone therapy market is currently estimated to be ... pharmacokinetic guidelines for the approval of testosterone therapy products for male hypogonadism. The trial ...

Methadone Frequently Causes Menopausal Symptoms in Young Women

... -- Methadone medication frequently depresses estradiol, progesterone and testosterone hormone levels to menopausal levels, even in women less than thirty years ... old, who we detoxed from methadone arrived with estradiol, progesterone or testosterone hormone levels, in the post menopausal range." A 1975 University ...

Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia

... study, BPH was induced in rats through subcutaneous injection of testosterone propionate (TP). One week after initiation of BPH, either D-3263, ... is a known inhibitor of 5-alpha reductase, the enzyme that converts testosterone to DHT, D-3263 is not an inhibitor of this enzyme suggesting that the two ...

BN ImmunoTherapeutics Announces Positive Mature Phase II Results From Newly Acquired Prostate Cancer Vaccine

... treatment. Hormone therapy slows the tumor growth by stopping or blocking testosterone from entering the cancer cells. Prostate cancer cells are typically dependent on testosterone or other androgens as growth factors. Thus, although initially effective, ...

Bavarian Nordic Announces Positive Mature Phase II Results From Newly Acquired Prostate Cancer Vaccine

... treatment. Hormone therapy slows the tumor growth by stopping or blocking testosterone from entering the cancer cells. Prostate cancer cells are typically dependent on testosterone or other androgens as growth factors. Thus, although initially effective, ...

Debiopharm Moves Towards a New 6-Month Formulation of Decapeptyl(R) to Further Help Prostate Cancer Patients

... results showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < 1.735 nmol/L or 50 ng/dL) from ...

Sexual Function Affected by Stem Cell Transplant According to Long-Term Study

... lining that can contribute to sexual dysfunction in women. For males, testosterone levels and the cavernosal arteries of the penis are affected, eroding ... improve by one to two years after treatment, but that methods such as testosterone replacement, erectile-function medications, and other adaptive strategies ...

Is Your Hair Taking a Break?

... hair loss) for women of non-childbearing age only, and the anti-androgens spironolactone and flutamide that work by blocking the male hormone testosterone at the cellular level of the hair follicle. These oral medications also may be an option for women who may not want to spend time applying minoxidil ...

Salvacyl(R), Developed by Debiopharm, is Launched in two European Countries

... substance triptorelin, a gonadotropin releasing hormone (GnRH) agonist analogue. The product will be prescribed for the reversible reduction of serum testosterone to the level of castration in order to lower sexual drive in adult men suffering from sexual deviations. "This is a great accomplishment for ...

Neurocrine Biosciences Presents Elagolix Data

... information on changes in prostate size, weight, hormone levels and cell immunohistochemistry. The data reveal that transient inhibition of plasma testosterone and intra-prostatic androgens results in the reduction of prostate weight, a reduction in epithelial proliferation and suppression of prostate ....

BIOCOM's 4th Annual DeviceFest Honors Companies

... diseases and disorders associated with aging, including insulin resistance, diabetes, neuropathy, cardiovascular disease, Alzheimer's and declining testosterone levels. Flexiciser received the "Life Changing" award for its device designed to improve movement to individuals who are unable to maintain the ...

Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture

... developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has four projects in clinical ...

Prostate Cancer Treatment Offers Results Without Side Effects

... dysfunction), incontinence (urine leakage) or a host of other side effects. He went on a raw food diet, had his dental amalgams removed and took testosterone blockers, which also eliminated his libido. He joined a clinical trial, but his cancer began to spread and he lost an alarming amount of weight. ...

Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder

... is a synthetic hormone known as a luteinizing hormone releasing hormone (LHRH) agonist, which suppresses the production of testosterone in the testicles. The growth of the prostate is regulated in part by the level and activity of testosterone. TRELSTAR(R) is available in a 4-week ...

Dendreon Presents Preclinical Data Demonstrating Activity of Trp-p8 agonist, D-3263, in Benign Prostatic Hyperplasia

... Meeting in Orlando, Fla., on Wednesday, May 21, 2008, at 2:50 PM ET. In a preclinical study, BPH was induced through subcutaneous injection of testosterone propionate (TP). One week prior to initiation of testosterone, either D-3263 or finasteride, a current treatment for BPH, was administered daily for ...

MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection

... infection, which has already completed two Phase 3 trials. Our other clinical stage product candidate, Opterone(R), is a topically applied SEPA-based testosterone cream designed to treat male hypogonadism. Our pipeline of clinical-stage and early-stage product candidates is based on our SEPA, MacroDerm(TM) and ...

Clinical Update - Decapeptyl(R)/Trelstar(R) 6-Month Formulation in Advanced Prostate Cancer

... of triptorelin 6-month formulation in 120 patients with advanced prostate cancer, showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < or equal to ...

Male Birth Control Pill, Blackberry Extract for Gingivitis, Skin Cancer and Digestive Health Top List of New Medical Discoveries

... inhibits infertility by utilizing a non-steroidal hormonal therapy known as a selective androgen receptor modulator. "Past clinical studies using testosterone for male contraception were not effective at preventing pregnancy without producing significant negative side- effects," said James Dalton, Ph.D., ...

MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera

... onychomycosis, a condition commonly known as nail fungus. Our other clinical stage product candidate, Opterone(R), is a topically applied SEPA-based testosterone cream designed to treat male hypogonadism. In addition to EcoNail and Opterone, our pipeline of early-stage product candidates is based on our SEPA, ...

Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years

... first and only dual 5ARI for the treatment of enlarged prostate, inhibits both the type I and type II isoenzymes responsible for the conversion of testosterone into dihydrotestosterone (DHT). DHT is the primary male hormone responsible for the enlargement of the prostate. AVODART provides the power to ...

New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia

... children or adolescents. The effects in these populations are unknown. Avoid taking ROZEREM with alcohol. ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in ...

Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)

... developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has four projects in clinical ...

Auxilium Announces New Data That Show Total Testosterone Blood Levels Increase Significantly Following Switch from AndroGel(R) to Testim(R)

... of hypogonadal men after switching brands of testosterone replacement gel therapy. Total ... at , records of 370 hypogonadal men on once-daily testosterone gel replacement therapy (Testim or AndroGel) were ... or patient preference. "Patients using testosterone replacement gel therapy sometimes will fail to ...

Repros' Androxal Shows Highly Statistically Significant Positive Effects in Men with Secondary Hypogonadism

... at month three who showed morning total serum testosterone concentrations within the normal ... in the 12.5mg and 25mg treatment arms with total testosterone in the physiological range at month three ... 0.0001). At month three, the mean improvement in testosterone levels was 184.3 and 259.2 ng/dl for both the ...

Indevus Reports Positive Data From Phase III NEBIDO Trial

... a long- acting injectable testosterone therapy under development for the treatment of ... pharmacokinetic guidelines for the approval of testosterone therapy products for male hypogonadism. The ... and an outlier analysis (based on the maximum testosterone concentrations during the steady state dosing ...

New Poll Shows Men, Women Incorrectly Blame Symptoms of Low Testosterone on Normal Aging

... believe their male partner's symptoms of low testosterone negatively impact their relationship, treatment ... of the relationship. Low testosterone, or testosterone deficiency associated with hypogonadism, is a ... gland that inhibits hormone secretion and testosterone production in men. As many as five million men ...

Repros' Proellex Shows Statistically Significant Improvement in Primary Endpoint in Phase 2 Trial in the Treatment of Uterine Fibroids

... other program in late clinical development, is designed to restore normal testosterone production by the testes and is being tested in a non-pivotal U.S. Phase 3 clinical trial for the treatment of testosterone deficiency in men due to secondary hypogonadism. For more information, ...

Repros Reports That Proellex Has Demonstrated Superior Efficacy and Safety in Endometriosis When Compared to Standard of Drug Care

... program in late clinical development, is designed to restore normal testosterone production by the testes in men and has recently completed a six-month U.S. non-pivotal Phase 3 clinical trial for the treatment of testosterone deficiency due to secondary hypogonadism. According to industry sources, ...

New Analysis of WHI Data Shows Reduced Levels of Coronary Artery Calcification, a Predictor of Cardiovascular Events, in Women aged 50-59 taking Estrogen Therapy

... Pharmaceuticals, Inc., BioSante's licensee, and LibiGel(R) (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel(TM), a testosterone gel for male hypogonadism, and an oral contraceptive using BioSante ...
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