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| Name | Class |
|---|---|
| Clarus Therapeutics, Inc. | INDUSTRY |
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The purpose of this research study is to evaluate patient satisfaction with an oral testosterone agent, Jatenzo, compared to other forms of testosterone therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jatenzo Arm | Experimental | Participants in this group will receive Jatenzo for 26 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jatenzo | Drug | 237 mg soft gel capsule taken twice a day by mouth with food. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| 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). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Testosterone Levels | Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw | Up to 6 months |
| Serum Estradiol Levels | Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw. |
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Inclusion Criteria:
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 or 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:
Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) >150 or Diastolic Blood Pressure (DBP) > 90 on two separate measurements
Concurrent use of any prohibited medications that can affect testosterone levels or metabolism.
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, or current or suspected, pituitary abnormality.
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.
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.
Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo
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| Name | Affiliation | Role |
|---|---|---|
| Ranjith Ramasamy, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Some participants did not complete all of the study visits due to non compliance with the protocol. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment | Chronic Kidney Disease requiring Kidney Transplant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ranjth Ramasamy | University of Miami, Miller School of Medicine - Desai Sethi Urology Institute | 305-243-6596 | Ramasamy@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2020 | Nov 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| Up to 6 months |
| Hematocrit Levels | Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw. | Up to 6 months |
| PSA Levels Measured in ng/mL | Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw. | Up to 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| 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). | Some participants did not complete all of the study visits due to non compliance with the protocol. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 6 months |
|
|
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| Secondary | Serum Testosterone Levels | Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw | Some participants did not complete all of the study visits due to non compliance with the protocol. | Posted | Mean | 95% Confidence Interval | ng/dL | Up to 6 months |
|
|
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| Secondary | Serum Estradiol Levels | Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw. | 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. | Posted | Mean | 95% Confidence Interval | pg/mL | Up to 6 months |
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|
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| Secondary | Hematocrit Levels | Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw. | Some participants did not complete all of the study visits due to non-compliance with the protocol. | Posted | Mean | 95% Confidence Interval | percentage of hematocrit | Up to 6 months |
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|
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| Secondary | PSA Levels Measured in ng/mL | Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw. | 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. | Posted | Mean | 95% Confidence Interval | ng/mL | Up to 6 months |
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| 0 |
| 41 |
| 1 |
| 41 |
| 5 |
| 41 |
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| Polycythemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Month 6 |
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| Month 6 |
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| Month 6 |
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