Natesto Testosterone Nasal Gel for Hypogonadal Men
NCT05484167 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2022-12-21
Summary
To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.
Conditions
- Erectile Dysfunction
- Sexual Dysfunction
Interventions
- DRUG
-
Natesto Nasal Product
Nasal Gel used for 90 days then crossed over to placebo gel
- DRUG
-
A nasal gel with no active ingredients
Sponsors & Collaborators
-
Acerus Pharmaceuticals Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
James Hotaling, MS, MS · University of Utah, Division of Urology, Department of Surgery
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-01-01
- Primary Completion
- 2024-01-01
- Completion
- 2025-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
NCT02149264 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel
NCT04976595 ·Status: UNKNOWN ·Phase: PHASE4
-
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
NCT04439799 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
NCT01419236 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males
NCT00372008 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
NCT03452111 ·Status: COMPLETED ·Phase: PHASE2
-
Testosterone Treatment for Hypogonadal Men
NCT00433199 ·Status: COMPLETED ·Phase: PHASE3
-
The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
NCT00421460 ·Status: COMPLETED ·Phase: PHASE4
-
Natesto Spermatogenesis Reboot
NCT05381831 ·Status: COMPLETED ·Phase: PHASE4
-
Testosterone for Penile Rehabilitation After Radical Prostatectomy
NCT00848497 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
NCT01403116 ·Status: COMPLETED ·Phase: PHASE3
-
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
NCT00702650 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
NCT00975650 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
NCT01816295 ·Status: COMPLETED ·Phase: PHASE3
-
Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
NCT01786473 ·Status: UNKNOWN ·Phase: PHASE3
-
Testopel ® vs. Generic Testosterone Pellets.
NCT04523480 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
NCT01703741 ·Status: COMPLETED ·Phase: PHASE3
-
NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel
NCT00229593 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
NCT01993212 ·Status: COMPLETED ·Phase: PHASE3
-
Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma
NCT00631137 ·Status: TERMINATED ·Phase: NA
-
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR
NCT00425568 ·Status: COMPLETED
-
A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (P05815)
NCT00254553 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy, Pharmacokinetics and Safety of Testosterone
NCT01370369 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
NCT00857961 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
NCT01446042 ·Status: COMPLETED ·Phase: PHASE3