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Androgen Replacement Therapy
Natesto for Low Testosterone
Phase 4
Recruiting
Led By Kevin Campbell, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 26 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial will study if Natesto can help men on testosterone therapy to regain fertility while avoiding hypogonadal symptoms.
Who is the study for?
Men aged 18-64 with low testosterone (<350 ng/dL) and reduced sperm count, who have stopped testosterone treatments for at least 4 weeks. They should be in good health overall, seeking to father a child, and have either primary or secondary hypogonadism diagnosed.
What is being tested?
The trial is testing NatestoTM to see if it can relieve symptoms of low testosterone while helping men recover their sperm production for the purpose of conceiving.
What are the potential side effects?
Possible side effects include allergic reactions to ingredients in NatestoTM, issues related to nasal administration such as irritation or discomfort, and typical risks associated with testosterone therapy like mood changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in total motile sperm count
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NatestoTMExperimental Treatment1 Intervention
Participants in this group will receive Natesto for a 26 consecutive weeks treatment course
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Who is running the clinical trial?
Acerus PharmaceuticalUNKNOWN
University of FloridaLead Sponsor
1,395 Previous Clinical Trials
767,264 Total Patients Enrolled
Kevin Campbell, MDPrincipal InvestigatorUniversity of Florida
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a stroke or heart attack in the last 5 years.You have donated or lost a large amount of blood, or received a blood transfusion within the last 12 weeks.You have had a bad reaction to androgens, castor oil, or other ingredients in the product.You have abnormal findings in your breast exam that need further testing.You have a prostate exam that feels abnormal, or you have a high score on a questionnaire about your urinary symptoms.You have severe sleep apnea that has not been treated.You have had nasal or sinus problems, surgery, or trauma in the past 6 months.Your body mass index (BMI) is 40 or higher.You have had a vasectomy in the past.Your blood tests show abnormal levels of certain substances, such as hemoglobin or PSA.Your testosterone levels are low, and you have symptoms like low energy and sexual function, or reduced sperm count.You stopped using testosterone replacement treatment and waited 4 weeks before starting the study.You do not have a suitable vein for multiple blood samples to be taken.You have taken any experimental medication within the past 4 weeks or within 5 half-lives before starting the treatment.Men between 18 and 64 years old with low testosterone and fertility issues who want to have a baby.You have a history of seizures or convulsions, including those caused by fever, alcohol, or drug withdrawal.You have a history of heavy drinking or drug use in the past 2 years, according to the doctor.You have had, currently have, or are suspected to have prostate or breast cancer.You have been diagnosed with a condition that affects the function of your reproductive glands.
Research Study Groups:
This trial has the following groups:- Group 1: NatestoTM
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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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