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Axiron Medical Research Studies

Up-to-date List of Axiron Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Axiron Medical Research Studies

Rank Status Study
1 Recruiting Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
Condition: Sarcopenia
Interventions: Drug: Testosterone injection;   Drug: Testosterone gel
Outcome Measures: Muscle protein synthesis and breakdown with and without testosterone treatment following resistance exercise;   Serum and skeletal muscle cytokine levels and inflammatory signaling will be measured before and after a standardized bout of resistance exercise, both with and without testosterone treatment;   Comparison of anabolic response and inflammatory response in muscle treated with injected testosterone versus testosterone gel
2 Recruiting Testosterone for Penile Rehab After Radical Prostatectomy
Conditions: Low Testosterone Levels;   Erectile Dysfunction
Interventions: Drug: Testim® + Viagra®;   Drug: Placebo Testim® + Viagra®
Outcome Measures: The primary outcome of the study is to evaluate efficacy of testosterone replacement therapy (TRT) in men following radical prostatectomy in improving erectile function using the change in SHIM score at 6 months after initial screening visit.;   The secondary outcome measure includes the change in the IIEF, ADAM and EPIC scores 6 months after the initial screening visit.
3 Recruiting A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
Condition: Hypogonadism
Interventions: Drug: Testosterone Solution;   Drug: Placebo Solution
Outcome Measures: Proportion of Participants with Total Serum Testosterone Concentration within Normal Range (300 to 1050 ng/dL) at Week 12;   Change from Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores;   Change from Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
4 Recruiting Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
Conditions: Testosterone;   Trauma;   Brain Injury
Interventions: Drug: Androgel (Testosterone Gel);   Drug: Androgel Placebo
Outcome Measures: Functional Independence Measure (FIM);   NIH Toolbox
5 Recruiting Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism
Conditions: Type 2 Diabetes;   Hypogonadism
Intervention: Drug: Testosterone
Outcome Measures: Improvement in endothelial dependent and endothelial-independent vasodilatation;   Markers of endothelial function
6 Recruiting Effect of Testosterone Treatment on Embryo Quality
Conditions: Primary Ovarian Insufficiency;   Female Infertility Due to Diminished Ovarian Reserve
Interventions: Drug: Testosterone cream (0.5mg per gram);   Dietary Supplement: DHEA;   Drug: Placebo
Outcome Measures: Clinical and Ongoing Pregnancy;   Measures of Atresia;   Oocytes number
7 Recruiting Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.
Conditions: Circadian;   Exercise;   Testosterone
Intervention: Drug: Testosterone supplementation
Outcome Measures: Salivary testosterone concentration;   Serum testosterone;   Circulating microRNA in blood plasma
8 Recruiting Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
Condition: Peyronie's Disease
Interventions: Drug: Vitamin D2;   Drug: Vitamin E;   Drug: Testosterone Pellets
Outcome Measures: penile curvature;   sexual function
9 Recruiting Oral Testosterone for the Treatment of Hypogonadism
Condition: Hypogonadism
Intervention: Drug: TSX-002
Outcome Measures: Total serum testosterone;   Proportion of subjects with total serum testosterone levels above normal range;   Safety of TSX-002
10 Recruiting Metabolomics During Testosterone Therapy
Condition: Testosterone Deficiency
Intervention: Drug: Testosterone Therapy
Outcome Measures: Metabolomics;   Symptoms of Testosterone Deficiency;   Body Composition;   Fasting insulin and glucose;   Lipid Profile
11 Recruiting Testosterone and Pain Sensitivity
Conditions: Low Testosterone;   Hypogonadism;   Pain
Interventions: Drug: Testosterone Gel;   Drug: Placebo Gel
Outcome Measures: Pain Tolerance - CPT;   Pain Tolerance - PPT;   QOL;   Pain Tolerance - TPPT;   Hormonal Outcomes
12 Recruiting Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
Condition: Heart Failure
Interventions: Drug: Testosterone undecanoate;   Drug: Saline isotonic solution
Outcome Measures: Death;   Mortality;   Hospital readmissions for any reason.;   Number of decompensated heart failure who have required intravenous medication for stabilization.;   Changes in test quality of life (Minnesota Living Heart Failure) and clinical modified Framingham score.;   Changes in cardiac function parameters assessed by echocardiography and natriuretic peptide (NT)-proBNP concentration.
13 Recruiting Exercise Training and Testosterone Replacement in Heart Failure Patients
Condition: Heart Failure
Interventions: Drug: Testosterone replacement;   Other: Exercise training
Outcome Measures: Microneurography;   Forearm blood flow;   Cardiopulmonary exercise;   Body composition;   Muscle biopsy
14 Recruiting T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin, Which Regulates Blood Sugar Levels
Conditions: Insulin Resistance;   Type 2 Diabetes Mellitus;   Obesity;   Androgen Deficiency;   Metabolic Disease
Interventions: Drug: Acyline;   Drug: Testosterone 1.62% gel;   Drug: Letrozole;   Drug: Placebo gel (for Testosterone 1.62% gel);   Drug: Placebo pill (for Letrozole)
Outcome Measures: Insulin sensitivity;   Changes in body composition;   Changes in adipose tissue gene expression
15 Recruiting The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men
Condition: Sarcopenia
Interventions: Drug: Testosterone enanthate;   Drug: Placebo
Outcome Measures: Muscle Strength;   Lean Body Mass and Muscle Volume;   Bone density;   Assessment of risk factors;   Assessment of Physical Performance;   Assessment of muscle signaling;   Assessment of bone metabolism.;   Assessment of Inflammation;   Assessment of cardiac stiffness
16 Not yet recruiting RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study)
Condition: Prostate Cancer
Interventions: Drug: Testosterone cypionate;   Drug: Testosterone Enanthate;   Drug: Abiraterone acetate;   Drug: Enzalutamide
Outcome Measures: PSA response to Bipolar Androgen Therapy;   PSA response to enzalutamide or abiraterone acetate post Bipolar Androgen Therapy;   PSA progression on enzalutamide or abiraterone acetate post-BAT;   PSA progression on BAT (Bipolar Androgen Therapy );   Measurable disease response;   initiation of docetaxel chemotherapy;   Quality of life;   Safety and Tolerability;   Fasting glucose;   hemoglobin A1c;   Fasting insulin;   Serum N-telopeptide;   Osteocalcin
17 Recruiting Testosterone Replacement in Metabolic Syndrome and Inflammation
Conditions: Hypogonadism;   Metabolic Syndrome;   Obesity;   Erectile Dysfunction
Interventions: Drug: Testosterone;   Drug: Placebo
Outcome Measures: Fat-Free Mass (kg);   Fat Mass (kg);   HOMA-IR (homeostasis model assessment)- (insulin resistance);   CRP (C reactive protein);   Interleukins;   Adipokines;   Waist circumference;   IIEF;   Penile CDU (color Doppler ultrasound);   PSA (prostatic specific antigen);   Hb, Htc;   Fat-free mass;   Fat Mass;   HOMA-IR;   CRP
18 Not yet recruiting Testosterone Undecanoate and Quality of Life of Men and Spouses
Condition: Hypogonadism
Intervention: Drug: testosterone undecanoate
Outcome Measure: patient and spouse satisfaction an quality of life
19 Recruiting Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)
Conditions: Nonalcoholic Steatohepatitis;   Hypogonadism
Intervention: Drug: testosterone undecanoate
Outcome Measures: steatosis histology;   Proportion of patients in whom liver inflammation improves;   Proportion of patients in whom liver ballooning improves;   Proportion of patients in whom liver fibrosis improves;   Change in fat content of liver;   Change in HOMA index;   Change in serum liver enzymes;   Adverse events
20 Not yet recruiting A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
Condition: Adult Male Hypogonadism
Intervention: Drug: Testosterone Gel (FE 999303)
Outcome Measures: The percentage of subjects whose average concentration (Cave(0-24)) serum total testosterone levels are ≥300 and ≤1050 ng/dL;   The percentage of subjects whose Cave(0-24) serum total testosterone levels are ≥300 and ≤1050 ng/dL;   Change from baseline in International Index of Erectile Function (IIEF) score;   Change from baseline in Multidimensional Assessment of Fatigue (MAF) score;   Change from baseline in Short Form-12 Health Survey (SF-12) score;   Average concentration (Cave) for total testosterone and dihydrotestosterone;   Area under the concentration-time curve (AUCτ) for total testosterone and dihydrotestosterone;   Time at which the maximum concentration occurs (Tmax) for total testosterone and dihydrotestosterone;   Maximum concentration observed (Cmax) for total testosterone and dihydrotestosterone;   Minimum concentration observed (Cmin) for total testosterone and dihydrotestosterone

These studies may lead to new treatments and are adding insight into Axiron etiology and treatment.

A major focus of Axiron research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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