Hypogonadism Clinical Trial
Official title:
A Randomized, Parallel, Double-dummy, Multi-center Phase III Study for Evaluation of Efficacy and Safety of Nasotestt Compared to Androgel Treating Hypogonadism in Male Research Participants.
This is a phase III study for evaluation of Nasotestt efficacy compared to Androgel in the treatment of male participants with hypogonadism condition (reduced levels of testosterone) that have clinical indication of hormonal replacement with testosterone.
This efficacy and safety study will evaluate the superiority of Nasotestt (nasal gel) treatment compared to Androgel (topic gel) after 60 days of starting use. The efficacy endpoint will be verified through the percentage of participants which presented at the end of 60 days normalized levels of total testosterone (<300 ng/dL to >1050 ng/dL). Secondary efficacy endpoints will be collected throughout the study through: evaluation of symptoms of erectile dysfunction (The International Index of Erectile Function - IIEF), symptoms of prostatic disease (International Prostate Symptom Score - IPSS), measurement of abdominal perimeter and clinical global response to treatment (CGI-I questionnaire). As exploratory investigation, the satisfaction/comfort of Nasotestt use will be assessed by a specific questionnaire that will be applied to participants at the end of study. Safety evaluation data will include report of all adverse events, including type, frequency, intensity, seriousness, severity and action taken related to the investigational product of the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
| Terminated |
NCT02419105 -
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
|
Phase 3 | |
| Withdrawn |
NCT02137265 -
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
|
N/A | |
| Completed |
NCT02233751 -
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
|
Phase 1 | |
| Completed |
NCT02222558 -
Oral Testosterone for the Treatment of Hypogonadism in Males
|
Phase 2 | |
| Completed |
NCT01887418 -
Pharmacokinetic Study of Testosterone Enanthate
|
Phase 1/Phase 2 | |
| Terminated |
NCT01092858 -
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
|
Phase 4 | |
| Completed |
NCT00624624 -
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
|
N/A | |
| Completed |
NCT00752869 -
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
|
Phase 4 | |
| Completed |
NCT00613288 -
Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
|
N/A | |
| Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
N/A | |
| Completed |
NCT00119483 -
Older Men and Testosterone
|
N/A | |
| Completed |
NCT00004438 -
Leuprolide in Treating Adults With Hypogonadotropism
|
N/A | |
| Withdrawn |
NCT00398034 -
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
|
Phase 2 | |
| Completed |
NCT02921386 -
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
|
Phase 2 | |
| Completed |
NCT02937740 -
Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™
|
Phase 4 | |
| Completed |
NCT01717768 -
Oral Testosterone for the Treatment of Hypogonadism
|
Phase 2 | |
| Terminated |
NCT01460654 -
Testosterone and Alendronate in Hypogonadal Men
|
Phase 2 | |
| Completed |
NCT00998933 -
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
|
Phase 1 | |
| Completed |
NCT00857454 -
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
|
Phase 3 |