A Phase 4 interventional study of Testosterone Cypionate 200 Mg/ML and Intranasal Testosterone in Hypogonadism, Male, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate changes in vascular parameters and the prevalence of side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to participant with clinical hypogonadism.
Administration of exogenous testosterone as efficacious treatment for male hypogonadism has been part of medical practice for more than 50 years. Testosterone replacement therapy (TRT) is becoming more widely available and has seen a greater than three-fold increase in use in men 40 years and older. Current delivery systems of TRT include transdermal gels and patches, intranasal gels (currently marketed as Natesto), injection therapy, and long acting subcutaneous pellets.
Natesto is a short-acting formulation of testosterone delivered intranasally to men diagnosed with low T. This has the potential to avoid side effects related to TRT that are commonly seen with other delivery methods, namely polycythemia, acne, male-pattern hair loss, azoospermia and hyperestrogenemia.
Testosterone Cypionate injections are the most common form of TRT in the USA. Testosterone Cypionate has many reported side effects, the most common being polycythemia, gynecomastia, hair loss, acne, decreased spermatogenesis, and testicular atrophy. In a multicenter retrospective study, it has been shown that the prevalence of polycythemia in men on testosterone replacement (injections) was 11.2%. In this study, we will compare hematocrit changes caused by treatment with Testosterone Cypionate and Natesto in a parallel arm, randomized study. To date, there have been no direct head-to-haed comparisons of these formulations.
We hypothesize that the short-acting pharmacokinetics of Natesto more closely resembles the natural pulsatility of testosterone and therefore can avoid side effects traditionally seen in long-acting, exogenous testosterone formulations
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 81 is above the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
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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).
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.
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 the intramuscular Testosterone Cypionate intervention for four months
Drug: Testosterone Cypionate 200 Mg/ML
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Drug: Intranasal Testosterone
Drug page: Testosterone 17 beta-cypionate
Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,
Also known as: Natesto
Change in Hematocrit (Hct) Levels.
Changes in serum Hematocrit levels will be assessed in percentage
Time frame: Baseline to 4 months
Change in Hormone Levels
Change in serum hormone levels including Testosterone, 17-Hydroxyprogesterone (17-OHP) assessed in ng/dL.
Time frame: Baseline to 4 months
Change in PSA Levels
Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL.
Time frame: Baseline to 4 months
Change in Estradiol Levels
Change in serum estradiol levels will be assessed in pg/mL.
Time frame: Baseline to 4 months
Changes in IIEF-6 Score
The International Index of Erectile Function (IIEF)-6 is a 6-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-30 with the higher score indicating better erectile function.
Time frame: Baseline to 4 months
| Milestone | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Started | 41 | 40 |
| Completed | 31 | 23 |
| Not completed | 10 | 17 |
| Withdrew: Lost to follow-up | 6 | 6 |
| Withdrew: Withdrawal by subject | 2 | 6 |
| Withdrew: Adverse event | 2 | 5 |
Changes in serum Hematocrit levels will be assessed in percentage
| percentage of hematocrit | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Change in Hematocrit (Hct) Levels. | 3.0 (2.8 to 5) | -0.6 (-1.5 to 0.4) |
Change in serum hormone levels including Testosterone, 17-Hydroxyprogesterone (17-OHP) assessed in ng/dL.
| ng/dL | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Testosterone | 511 (373 to 650) | 283 (149 to 417) |
| 17-OHP | -39.8 (-53.1 to -26.5) | -8.8 (-24.4 to 6.7) |
Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL.
| ng/mL | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Change in PSA Levels | 0.6 (-0.02 to 1.23) | 0.05 (-0.22 to 0.32) |
Change in serum estradiol levels will be assessed in pg/mL.
| pg/mL | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Change in Estradiol Levels | 22.9 (11 to 34.8) | 1.1 (-5.7 to 7.8) |
The International Index of Erectile Function (IIEF)-6 is a 6-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-30 with the higher score indicating better erectile function.
| score on a scale | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Changes in IIEF-6 Score | 4.8 (1.1 to 8.5) | 0.2 (-3.6 to 4) |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Testosterone Cypionate Group | 0/41 (0%) | 0/41 (0%) | 2/41 (4.9%) |
| Natesto Group | 0/40 (0%) | 0/40 (0%) | 5/40 (12.5%) |
| Event | Testosterone Cypionate Group | Natesto Group |
|---|---|---|
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 0/41 | 3/40 |
| LabyrithitisEar and labyrinth disorders | 0/41 | 1/40 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/41 | 1/40 |
| Generalized EdemaGeneral disorders | 1/41 | 0/40 |
| AnemiaBlood and lymphatic system disorders | 1/41 | 0/40 |
| Age, Continuous(years) | Testosterone Cypionate Group | Natesto Group | Total |
|---|---|---|---|
| Mean | 48.46 ± 11.86 | 48.2 ± 10.89 | 48.33 ± 11.32 |
| Sex: Female, Male(Participants) | Testosterone Cypionate Group | Natesto Group | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 41 | 40 | 81 |
| Ethnicity (NIH/OMB)(Participants) | Testosterone Cypionate Group | Natesto Group | Total |
|---|---|---|---|
| Hispanic or Latino | 29 | 22 | 51 |
| Not Hispanic or Latino | 12 | 18 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Testosterone Cypionate Group | Natesto Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 9 | 9 |
| White | 40 | 29 | 69 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Testosterone 17 beta-cypionate · Testosterone