Phase 4
N=81
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
Hypogonadism, Male
Bottom Line
View on ClinicalTrials.gov: NCT04439799 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Hematocrit (Hct) Levels. — 3.0; -0.6 percentage of hematocrit
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Testosterone Cypionate 200 Mg/ML (Drug); Intranasal Testosterone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hematocrit (Hct) Levels. |
3.0; -0.6 | — |
| SECONDARY Change in Hormone Levels |
511; 283; -39.8; -8.8 | — |
| SECONDARY Change in PSA Levels |
0.6; 0.05 | — |
| SECONDARY Change in Estradiol Levels |
22.9; 1.1 | — |
| SECONDARY Changes in IIEF-6 Score |
4.8; 0.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Voluntarily sign and date the study consent form(s), which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
- Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
- Serum total testosterone 16 g/dL or Hematocrit (HCT) 48%
- Prostate Specific Antigen (PSA) > 4 ng/mL
- History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
- History of stroke or myocardial infarction within the past 5 years.
- History of, or current or suspected, prostate or breast cancer.
- History of diagnosed, severe, untreated, obstructive sleep apnea.
- History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
- Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
- Receipt of any subcutaneous testosterone pellets within the last 6 months.
- Inability to understand and provide written informed consent for the study.
Data sourced from ClinicalTrials.gov (NCT04439799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.