Testopel ® vs. Generic Testosterone Pellets.

Phase 3

Completed

Conditions: Hypogonadism

Interventions: Drug: Testopel 200mg Drug Implant
Drug: Testopel 75mg Drug Implant
Drug: Testopel 100mg Drug Implant

Registration Number: NCT04523480

Lead Sponsor: University of Miami

Brief Summary: The purpose of this study is to evaluate changes in vascular parameters in subjects receiving Testopel 75mg (one time) versus subjects receiving Compounded Testosterone pellets 100mg (one time) versus subjects receiving Compounded Testosterone pellets 200mg (one time) to participant with clinical hypogonadism.

Detailed Description: Hypogonadism, or low testosterone (Low T), is the deficiency in producing testosterone by the testes. Testosterone pellets is a long-acting formulation of Testosterone Replacement Therapy (TRT) that is delivered subcutaneously to men diagnosed with low T. Advantages to subcutaneous testosterone pellets include ease of delivery and decreased risk of the medication being transfer upon skin contact to woman or children. Long acting testosterone replacement Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total testosterone into the therapeutic range at 1 month post-implantation and sustained therapeutic levels (\>300) for 4-6 months.

Participants will be randomly assigned to 1 of 3 study groups. In one of the groups the treatment will include implantation of Testopel ® 750mg (10 pellets with 75mg pellet) one time, in the second group, treatment will include compounded subcutaneous testosterone 800mg (8 pellets with 100mg pellet) one time and in the third group, treatment will include compounded subcutaneous testosterone 800mg (4 pellets with 200mg pellet) one time.

The treatment takes approximately 30 minutes and will include: Clean and numb the insertion site with lidocaine at 1%, followed by small incision in the skin, implantation of pellets into subdermal fat layer and sealing the incision with Steri-strip. This is the current standard of care of Testopel insertion and same procedure will be followed with both compounded and commercial pellets.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 75

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.
Male between 18 and 75 years of age.
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 weeks following androgen treatment.
Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria

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) or International Prostate Symptom Score (I-PSS) score > 19 points.
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:
1. Baseline hemoglobin > 16 g/dL
2. Hematocrit < 35% or > 50%
3. 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 investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
Inability to understand and provide written informed consent for the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compounded Testosterone pellets 200mg Group	Testopel 200mg Drug Implant	Participants in this group will receive a one-time subcutaneous testosterone insertion of 4 x 200 mg compounded testosterone for a total of 800 mg compounded testosterone.
Testopel 75mg Group	Testopel 75mg Drug Implant	Participants in this group will receive a one-time subcutaneous testosterone insertion of 10 x 75 mg pellets of Testopel for a total of 750 mg Testopel.
Compounded testosterone pellets 100mg Group	Testopel 100mg Drug Implant	Participants in this group will receive a one-time subcutaneous testosterone insertion of 8 x 100 mg compounded testosterone for a total of 800 mg compounded testosterone.

Primary Outcome Measures

Name	Time	Method
Change in Testosterone (T) Levels	Baseline, 2 months, 4 months, and 6 months	Changes in serum Testosterone levels are assessed in ng/dL

Secondary Outcome Measures

Name	Time	Method
Change in PSA Levels	Baseline, 2 months, 4 months, and 6 months	Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.
Change in Estradiol Levels	Baseline, 2 months, 4 months, and 6 months	Change in serum estradiol levels are assessed in pg/mL.
Change in Hematocrit (Hct) Levels.	Baseline, 2 months, 4 months, and 6 months	Changes in serum Hct levels are assessed in %.