Hypogonadism
Conditions
Keywords
Low T, Low Testosterone
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.
Interventions
DRUGTestopel 75mg Drug Implant
75 mg Testosterone pellets administered subcutaneously.
DRUGTestopel 100mg Drug Implant
100 mg Testosterone pellets administered subcutaneously.
DRUGTestopel 200mg Drug Implant
200 mg Testosterone pellets administered subcutaneously.
Sponsors
Empower Research Inc
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Testosterone (T) Levels | Baseline, 2 months, 4 months, and 6 months | Changes in serum Testosterone levels are assessed in ng/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hematocrit (Hct) Levels. | Baseline, 2 months, 4 months, and 6 months | Changes in serum Hct levels are assessed in %. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testopel 75mg Group 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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously. | 33 |
| Compounded Testosterone Pellets 100mg Group 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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously. | 42 |
| Compounded Testosterone Pellets 200mg Group 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 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously. | 0 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 30 | 35 | 0 |
Baseline characteristics
| Characteristic | Testopel 75mg Group | Compounded Testosterone Pellets 100mg Group | Total | Compounded Testosterone Pellets 200mg Group |
|---|---|---|---|---|
| Age, Continuous | 54.5 years | 52.5 years | 53.5 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 29 Participants | 53 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 13 Participants | 22 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 9 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 29 Participants | 53 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 13 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 42 Participants | 75 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 42 | 0 / 0 |
| other Total, other adverse events | 1 / 33 | 0 / 42 | 0 / 0 |
| serious Total, serious adverse events | 0 / 33 | 0 / 42 | 0 / 0 |
Outcome results
Primary
Change in Testosterone (T) Levels
Changes in serum Testosterone levels are assessed in ng/dL
Time frame: Baseline, 2 months, 4 months, and 6 months
Population: Zero participants were enrolled into the Compounded Testosterone pellets 200mg Group due to the pharmacy being unable to produce the investigational product at that dosage amount.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testopel 75mg Group | Change in Testosterone (T) Levels | Month 4 | 290 ng/dL |
| Testopel 75mg Group | Change in Testosterone (T) Levels | Baseline | 219.5 ng/dL |
| Testopel 75mg Group | Change in Testosterone (T) Levels | Month 6 | 209 ng/dL |
| Testopel 75mg Group | Change in Testosterone (T) Levels | Month 2 | 543 ng/dL |
| Compounded Testosterone Pellets 100mg Group | Change in Testosterone (T) Levels | Month 6 | 241 ng/dL |
| Compounded Testosterone Pellets 100mg Group | Change in Testosterone (T) Levels | Baseline | 202.3 ng/dL |
| Compounded Testosterone Pellets 100mg Group | Change in Testosterone (T) Levels | Month 4 | 277 ng/dL |
| Compounded Testosterone Pellets 100mg Group | Change in Testosterone (T) Levels | Month 2 | 696.5 ng/dL |
Secondary
Change in Estradiol Levels
Change in serum estradiol levels are assessed in pg/mL.
Time frame: Baseline, 2 months, 4 months, and 6 months
Population: Zero participants were enrolled into the Compounded Testosterone pellets 200mg Group due to the pharmacy being unable to produce the investigational product at that dosage amount.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testopel 75mg Group | Change in Estradiol Levels | Baseline | 18.2 pg/mL |
| Testopel 75mg Group | Change in Estradiol Levels | Month 2 | 29.1 pg/mL |
| Testopel 75mg Group | Change in Estradiol Levels | Month 4 | 13.7 pg/mL |
| Testopel 75mg Group | Change in Estradiol Levels | Month 6 | 14.3 pg/mL |
| Compounded Testosterone Pellets 100mg Group | Change in Estradiol Levels | Month 6 | 18.8 pg/mL |
| Compounded Testosterone Pellets 100mg Group | Change in Estradiol Levels | Baseline | 20.6 pg/mL |
| Compounded Testosterone Pellets 100mg Group | Change in Estradiol Levels | Month 4 | 18.4 pg/mL |
| Compounded Testosterone Pellets 100mg Group | Change in Estradiol Levels | Month 2 | 42.7 pg/mL |
Secondary
Change in Hematocrit (Hct) Levels.
Changes in serum Hct levels are assessed in %.
Time frame: Baseline, 2 months, 4 months, and 6 months
Population: Zero participants were enrolled into the Compounded Testosterone pellets 200mg Group due to the pharmacy being unable to produce the investigational product at that dosage amount.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testopel 75mg Group | Change in Hematocrit (Hct) Levels. | Baseline | 43.7 hematocrit percentage |
| Testopel 75mg Group | Change in Hematocrit (Hct) Levels. | Month 2 | 46.1 hematocrit percentage |
| Testopel 75mg Group | Change in Hematocrit (Hct) Levels. | Month 4 | 45.9 hematocrit percentage |
| Testopel 75mg Group | Change in Hematocrit (Hct) Levels. | Month 6 | 46 hematocrit percentage |
| Compounded Testosterone Pellets 100mg Group | Change in Hematocrit (Hct) Levels. | Month 6 | 43 hematocrit percentage |
| Compounded Testosterone Pellets 100mg Group | Change in Hematocrit (Hct) Levels. | Baseline | 42.8 hematocrit percentage |
| Compounded Testosterone Pellets 100mg Group | Change in Hematocrit (Hct) Levels. | Month 4 | 45.8 hematocrit percentage |
| Compounded Testosterone Pellets 100mg Group | Change in Hematocrit (Hct) Levels. | Month 2 | 46.7 hematocrit percentage |
Secondary
Change in PSA Levels
Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.
Time frame: Baseline, 2 months, 4 months, and 6 months
Population: Zero participants were enrolled into the Compounded Testosterone pellets 200mg Group due to the pharmacy being unable to produce the investigational product at that dosage amount.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Testopel 75mg Group | Change in PSA Levels | Baseline | 0.9 ng/mL |
| Testopel 75mg Group | Change in PSA Levels | Month 2 | 1.1 ng/mL |
| Testopel 75mg Group | Change in PSA Levels | Month 4 | 1 ng/mL |
| Testopel 75mg Group | Change in PSA Levels | Month 6 | 0.8 ng/mL |
| Compounded Testosterone Pellets 100mg Group | Change in PSA Levels | Month 6 | 0.5 ng/mL |
| Compounded Testosterone Pellets 100mg Group | Change in PSA Levels | Baseline | 0.4 ng/mL |
| Compounded Testosterone Pellets 100mg Group | Change in PSA Levels | Month 4 | 0.65 ng/mL |
| Compounded Testosterone Pellets 100mg Group | Change in PSA Levels | Month 2 | 0.75 ng/mL |