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Androgen Replacement Therapy
Natesto vs Testosterone Injections for Low Testosterone
Phase 4
Waitlist Available
Led By Ranjith Ramasamy, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 months
Awards & highlights
Summary
This trial is testing whether a higher dose of testosterone given less often is as effective as a lower dose given more often, and whether either has side effects.
Eligible Conditions
- Testicular Hypogonadism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Hematocrit (Hct) Levels.
Secondary outcome measures
Change in Estradiol Levels
Change in Hormone Levels
Change in PSA Levels
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Testosterone Cypionate GroupActive Control1 Intervention
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Group II: Natesto GroupActive Control1 Intervention
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
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Who is running the clinical trial?
University of MiamiLead Sponsor
918 Previous Clinical Trials
412,548 Total Patients Enrolled
1 Trials studying Testicular Hypogonadism
60 Patients Enrolled for Testicular Hypogonadism
Acerus Pharmaceuticals CorporationIndustry Sponsor
13 Previous Clinical Trials
6,335 Total Patients Enrolled
2 Trials studying Testicular Hypogonadism
366 Patients Enrolled for Testicular Hypogonadism
Ranjith Ramasamy, MDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
12 Previous Clinical Trials
703 Total Patients Enrolled
1 Trials studying Testicular Hypogonadism
60 Patients Enrolled for Testicular Hypogonadism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a strong allergic reaction to androgens or any ingredients in the product.Your doctor has felt an unusual lump during a prostate exam.You had a stroke or heart attack in the last 5 years.You have had, currently have, or are suspected to have prostate or breast cancer.You have a severe, untreated breathing problem during sleep called obstructive sleep apnea.You have misused alcohol or drugs in the past 2 years according to the doctor.You have donated or lost a large amount of blood, or received a blood transfusion, within the past 12 weeks.It is difficult to draw blood from your veins for the required blood tests.You have been diagnosed with a condition that affects the function of your reproductive glands.You have a history of seizures or convulsions, including those caused by fever, alcohol, or drug withdrawal.You have not started taking or have stopped taking hormone replacement therapy for at least 4 months.Consent forms have been approved by an Institutional Review BoardMen who may need testosterone replacement therapy based on their medical history, physical exam, lab tests, and ECG.You have a very high body mass index (BMI), which means you are very overweight.Your blood test results show significant abnormalities, such as high hemoglobin or PSA levels.Your testosterone levels are lower than 300 ng/dL on two separate tests.
Research Study Groups:
This trial has the following groups:- Group 1: Testosterone Cypionate Group
- Group 2: Natesto Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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