A Phase 4 interventional study of Natesto in Hypogonadism, Male, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly.This will be a prospective case study. The investigators will identify men with hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT). Natesto is a relatively new form of testosterone replacement therapy that is delivered intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg testosterone/dose), three times a day (TID) dosing was shown to also increase serum testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone (T) \<350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between 6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be excluded.
Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly). While Natesto has been shown to have positive effects on Testosterone while maintaining LH and FSH, the impact on sperm count has not yet been proven.
Study Design and Duration of Treatment: Participants will take Natesto 11g intra nasally there times a day (TID) for 16 weeks (120 days) between serum and semen evaluations.
Subject Population: The study will identify men with confirmed hypogonadism (testosterone (T) \<350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between 6am and 10am with demonstrated symptoms of hypogonadism). Subjects with a history of prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be excluded.
Number of subjects: 40 participants will be enrolled and receive treatment with Natesto.
Study Duration:Total participation in the study will be approximately 24-28 weeks.
Study Procedures: Participants will undergo a total of six study visits. At the first visit, subjects will undergo screening procedures which will include signing of the consent form, physical exam, assessment for inclusion and exclusion criteria, Sexual Health Inventory in Men (SHIM) and quality of life questionnaire, blood sample for clinical laboratory assessment, and a semen analysis. At visit 2, subjects will undergo a second semen analysis and blood analysis for T. After 12 weeks (90 days), Participants will return for a third visit for blood sample and semen analysis as well as safety monitoring. The Participants will also be given SHIM and quality of life questionnaires. This procedure will be repeated at week 24 to get a final blood and semen analysis.
Study Endpoints: The primary endpoint will be change in FSH, LH, Estradiol, T, and Semen Analysis after 12 weeks and 24 weeks of treatment with Natesto. The secondary endpoint will be monitoring for adverse events
Statistical Methods: Analyses will consist of summaries of the values and total change from baseline in each value (visit value versus baseline value) using descriptive statistics (sample size, mean, median, standard deviation, 95% confidence interval, minimum, and maximum). The change from baseline in each endpoint will compared using a two-sample t-test, or the Wilcoxon rank sum test if distributional assumptions are violated. The primary time point of interest for assessing hormone effects is the week 12 visit.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 55 interventional studies indexed under Eunuchism.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.
Drug: Natesto
4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Change in Testosterone Levels From Baseline to 27 Weeks
Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
Time frame: Baseline, 27 Weeks
Change in Estradiol Levels From Baseline to 27 Weeks
Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw
Time frame: Baseline, 27 Weeks
Change in Gonadotropin Levels From Baseline to 27 Weeks
Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) levels, both measured in mIU/mL analyzed from peripheral venous puncture blood draw
Time frame: Baseline, 27 Weeks
Number of Participants With an Increase in SF-36 QOL Scores From Baseline
The number of participants with an increase of at least 1 point from their SF-36 QOL scores from baseline will be reported. Short Form-36 (SF-36) Quality of Life (QOL) questionnaire has a proprietary scoring system that ranges from 1-5 and each domain is individually assessed
Time frame: 27 Weeks
Change in Sperm Counts From Baseline to 27 Weeks
Sperm count measured in million sperm/mL analyzed from semen sample
Time frame: Baseline, 27 Weeks
Incidence of Adverse Events
Incidence of adverse events as assessed per treating physician
Time frame: 27 Weeks
| Milestone | Natesto |
|---|---|
| Started | 60 |
| 3 month | 44 |
| 6 months | 33 |
| Completed | 33 |
| Not completed | 27 |
Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
| ng/dL | Natesto |
|---|---|
| Change in Testosterone Levels From Baseline to 27 Weeks | 652 ± 305 |
Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw
| pg/mL | Natesto |
|---|---|
| Change in Estradiol Levels From Baseline to 27 Weeks | 21.6 ± 14 |
Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) levels, both measured in mIU/mL analyzed from peripheral venous puncture blood draw
| mIU/mL | Natesto |
|---|---|
| Follicle Stimulating Hormone | 3.0 ± 2.9 |
| Luteinizing Hormone | 2.6 ± 3.1 |
The number of participants with an increase of at least 1 point from their SF-36 QOL scores from baseline will be reported. Short Form-36 (SF-36) Quality of Life (QOL) questionnaire has a proprietary scoring system that ranges from 1-5 and each domain is individually assessed
| Participants | Natesto |
|---|---|
| Number of Participants With an Increase in SF-36 QOL Scores From Baseline | 32 |
Sperm count measured in million sperm/mL analyzed from semen sample
| million sperm/mL | Natesto |
|---|---|
| Change in Sperm Counts From Baseline to 27 Weeks | 33.9 ± 24.3 |
Incidence of adverse events as assessed per treating physician
| Participants | Natesto |
|---|---|
| Azoospermia | 1 |
| Severe Oligospermia | 3 |
| Nasal irritation | 5 |
| sinusitis | 1 |
| epistaxis | 1 |
Collected over 28 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Natesto | 0/60 (0%) | 4/60 (6.7%) | 5/60 (8.3%) |
| Event | Natesto |
|---|---|
| Severe OligospermiaReproductive system and breast disorders | 3/60 |
| AzoospermiaReproductive system and breast disorders | 1/60 |
| Event | Natesto |
|---|---|
| Nasal IrritationInjury, poisoning and procedural complications | 5/60 |
| SinusitisGeneral disorders | 1/60 |
| EpistaxisGeneral disorders | 1/60 |
| Age, Categorical(Participants) | Natesto |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 60 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Natesto |
|---|---|
| Female | 0 |
| Male | 60 |
| Race/Ethnicity, Customized(Participants) | Natesto |
|---|---|
| Demographics — Caucasian | 12 |
| Demographics — Black | 2 |
| Demographics — Hispanic | 34 |
| Demographics — Asian | 1 |
| Demographics — Other | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Natesto