Status:
COMPLETED
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Acerus Pharmaceuticals Corporation
Conditions:
Hypogonadism, Male
Eligibility:
MALE
18-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
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 mor...
Eligibility Criteria
Inclusion
- 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 \< 300 ng/dL on 2 measurements
- Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 months following androgen treatment.
- Men deemed to be candidates for TRT based on the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Exclusion
- History of significant sensitivity or allergy to androgens, or product excipients.
- Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s)
- Body mass index (BMI) ≥ 40 kg/m2.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- Baseline hemoglobin \> 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.
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04439799
Start Date
August 7 2020
End Date
February 9 2023
Last Update
December 13 2023
Active Locations (1)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136