Testosterone Deficiency
Conditions
Brief summary
The purpose of this research study is to evaluate patient satisfaction with an oral testosterone agent, Jatenzo, compared to other forms of testosterone therapy.
Interventions
DRUGJatenzo
237 mg soft gel capsule taken twice a day by mouth with food.
Sponsors
Clarus Therapeutics, Inc.
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Males between 18 and 65 years of age. 3. Documented diagnosis of testosterone deficiency. 4. Prior treatment with testosterone therapy at the time of enrollment with adequate control of low testosterone symptoms. Serum total testosterone \< 300 ng/dL on 2 measurements prior to the initiation of testosterone therapy. Patients must have completed an adequate washout period following prior testosterone therapy (4 weeks for gels and injection based therapies and 16 weeks for subcutaneous pellets). 5. 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
1. History of significant sensitivity or allergy to androgens or product excipients. 2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up or abnormal ECG. 3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \> 19 points. 4. Body mass index (BMI) ≥ 40 kg/m2. 5. 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% 6. Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) \>150 or Diastolic Blood Pressure (DBP) \> 90 on two separate measurements 7. Concurrent use of any prohibited medications that can affect testosterone levels or metabolism. 8. History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures. 9. History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration. 10. History of stroke or myocardial infarction within the past 5 years. 11. History of, or current or suspected, prostate or breast cancer. 12. History of, or current or suspected, pituitary abnormality. 13. History of diagnosed, severe, untreated, obstructive sleep apnea. 14. History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years. 15. Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment. 16. Inability to understand and provide written informed consent for the study. 17. Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) | Up to 6 months | Treatment Satisfaction Questionnaire for Medication (TSQM-9) has three domains (Global, Convenience, and Effectiveness), each with a total score ranging from 0 to 100 with the higher score indicating higher patient satisfaction. |
| Hypogonadal Symptoms as Measured by qADAM Questionnaire | Up to 6 months | Quantitative Androgen Deficiency in the Aging Male (qADAM) has a total score ranges between 10 (most symptomatic) and 50 (least symptomatic). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Testosterone Levels | Up to 6 months | Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw |
| Serum Estradiol Levels | Up to 6 months | Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw. |
| Hematocrit Levels | Up to 6 months | Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw. |
| PSA Levels Measured in ng/mL | Up to 6 months | Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Jatenzo Arm Participants in this group will receive Jatenzo for 26 consecutive weeks.
Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 14 |
Baseline characteristics
| Characteristic | Jatenzo Arm |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 5 / 41 |
| serious Total, serious adverse events | 1 / 41 |
Outcome results
Primary
Hypogonadal Symptoms as Measured by qADAM Questionnaire
Quantitative Androgen Deficiency in the Aging Male (qADAM) has a total score ranges between 10 (most symptomatic) and 50 (least symptomatic).
Time frame: Up to 6 months
Population: Some participants did not complete all of the study visits due to non compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jatenzo Arm | Hypogonadal Symptoms as Measured by qADAM Questionnaire | Month 6 | 35.5 score on a scale |
| Jatenzo Arm | Hypogonadal Symptoms as Measured by qADAM Questionnaire | Baseline | 36.6 score on a scale |
| Jatenzo Arm | Hypogonadal Symptoms as Measured by qADAM Questionnaire | Month 3 | 34.4 score on a scale |
Primary
Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain)
Treatment Satisfaction Questionnaire for Medication (TSQM-9) has three domains (Global, Convenience, and Effectiveness), each with a total score ranging from 0 to 100 with the higher score indicating higher patient satisfaction.
Time frame: Up to 6 months
Population: Some participants did not complete all of the study visits due to non compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jatenzo Arm | Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) | Baseline | 66.7 score on a scale |
| Jatenzo Arm | Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) | Month 3 | 83.1 score on a scale |
| Jatenzo Arm | Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) | Month 6 | 83.7 score on a scale |
Secondary
Hematocrit Levels
Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw.
Time frame: Up to 6 months
Population: Some participants did not complete all of the study visits due to non-compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jatenzo Arm | Hematocrit Levels | Baseline | 44.9 percentage of hematocrit |
| Jatenzo Arm | Hematocrit Levels | Month 3 | 45 percentage of hematocrit |
| Jatenzo Arm | Hematocrit Levels | Month 6 | 45.2 percentage of hematocrit |
Secondary
PSA Levels Measured in ng/mL
Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw.
Time frame: Up to 6 months
Population: PSA was added to the protocol during an amendment after the trial had begun. Some participants did not complete all of the study visits due to non-compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jatenzo Arm | PSA Levels Measured in ng/mL | Baseline | 1.06 ng/mL |
| Jatenzo Arm | PSA Levels Measured in ng/mL | Month 3 | 1.14 ng/mL |
| Jatenzo Arm | PSA Levels Measured in ng/mL | Month 6 | 0.95 ng/mL |
Secondary
Serum Estradiol Levels
Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw.
Time frame: Up to 6 months
Population: Estradiol was added to the protocol during an amendment after the trial had begun. Some participants did not complete all of the study visits due to non-compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jatenzo Arm | Serum Estradiol Levels | Baseline | 14.4 pg/mL |
| Jatenzo Arm | Serum Estradiol Levels | Month 3 | 21.6 pg/mL |
| Jatenzo Arm | Serum Estradiol Levels | Month 6 | 21.2 pg/mL |
Secondary
Serum Testosterone Levels
Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
Time frame: Up to 6 months
Population: Some participants did not complete all of the study visits due to non compliance with the protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jatenzo Arm | Serum Testosterone Levels | Baseline | 200.3 ng/dL |
| Jatenzo Arm | Serum Testosterone Levels | Month 3 | 486.8 ng/dL |
| Jatenzo Arm | Serum Testosterone Levels | Month 6 | 649.3 ng/dL |