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Natesto vs Testosterone Injections for Low Testosterone
Study 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.
- Testicular Hypogonadism
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Testosterone Cypionate Group
- Group 2: Natesto Group
- 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.
- 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.
Frequently Asked Questions
What health conditions can Natesto Group be utilized to treat?
"Natesto Group is a viable solution for treating vanishing testis syndrome, testicular hypogonadism and breast-related issues."
Is there any evidence of prior research involving Natesto Group?
"Currently, 32 clinical trials are investigating the effectiveness of Natesto Group with 5 in their final stage. Although most studies take place in Houston, Texas; 134 sites across the US are offering this medication as part of a trial."
Is this research project currently accepting participants?
"As per the data available on clinicaltrials.gov, this trial has ceased recruitment of participants. It was first posted on August 7th 2020 and last updated October 17th 2022; however, there are 67 other trials that are seeking patients as we speak."
Could I qualify to partake in this experiment?
"Those who wish to join this medical trial must be between the ages of 18 and 75, in addition to having a diagnosis of hypogonadism. Approximately 200 patients need to be recruited for the study."
Do the eligibility requirements for participation in this trial include individuals of advanced age?
"This trial is open to participants aged 18-75. Subcategories of the study have been allocated for those under 18, as well as a separate cohort of over 65s totalling 42 individuals."
What is the approximate number of participants involved in this clinical trial?
"Currently, this research project is not actively accepting participants. It was originally published on August 7th 2020 and updated most recently on October 17th 2022. For those seeking an alternative trial, there are 35 clinical trials for hypogonadism currently enrolling patients, as well as 32 Natesto Group studies looking for volunteers."
Has the Natesto Group been officially sanctioned by the FDA?
"Natesto Group's safety has been ascertained though a Phase 4 trial, which makes it eligible for approval. Consequently, there is strong evidence of the medication's security and our team at Power rated its safety with 3 out of 3 on their scale."
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