Testosterone DeficiencyPhase 4NCT04983940

Patient Satisfaction After Switching to Oral Testosterone Undecanoate

A Phase 4 study testing Jatenzo in people with Testosterone Deficiency, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Testosterone Deficiency
What is being tested?: Jatenzo
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 18 Jun 2021to 6 Apr 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Males between 18 and 65 years of age.
Documented diagnosis of testosterone deficiency.
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).
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).

Who cannot join

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:
Baseline hemoglobin > 16 g/dL

Show all 19Show fewer

Hematocrit < 35% or > 50%
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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Patient Satisfaction After Switching to Oral Testosterone Undecanoate in Men Currently on Testosterone Therapy

The purpose of this research study is to evaluate patient satisfaction with an oral testosterone agent, Jatenzo, compared to other forms of testosterone therapy.

Conditions: Testosterone Deficiency
Being tested: Jatenzo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JatenzoDrug
237 mg soft gel capsule taken twice a day by mouth with food.

Study groups in NCT04983940
Study group	Role	What they receive
Jatenzo Arm	Experimental	Participants in this group will receive Jatenzo for 26 consecutive weeks. Receives: Drug: Jatenzo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: Up to 6 months

Secondary outcomes (4)

Serum Testosterone Levels
Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
Measured: Up to 6 months
Serum Estradiol Levels
Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw.
Measured: Up to 6 months
Hematocrit Levels
Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw.
Measured: 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.
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 20216 Apr 2023

First posted30 Jul 2021
Study start18 Jun 2021
Primary completion6 Apr 2023
Study completion6 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Testosterone DeficiencyStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04983940
Sponsor's protocol ID: 20200971
Status last verified: Nov 2023
First submitted: 20 Jul 2021
Last updated: 14 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
Not yet recruiting
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
Menopause, Sexual Dysfunction
RecruitingPhase 2
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Metastatic Prostate Cancer
RecruitingObservational study
Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Testosterone Deficiency, Male Hypogonadism

All Testosterone Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Satisfaction After Switching to Oral Testosterone Undecanoate in Men Currently on Testosterone Therapy
ClinicalTrials.gov ID: NCT04983940
Acronym / sponsor ID: 20200971
Conditions: Testosterone Deficiency
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Clarus Therapeutics, Inc.
Study start: 18 Jun 2021 (actual)
Primary completion: 6 Apr 2023 (actual)
Study completion: 6 Apr 2023 (actual)
First posted: 30 Jul 2021 (actual)
Results: Posted 14 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research study is to evaluate patient satisfaction with an oral testosterone agent, Jatenzo, compared to other forms of testosterone therapy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Jatenzo Arm	Experimental	Drug: JatenzoParticipants in this group will receive Jatenzo for 26 consecutive weeks.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
Males between 18 and 65 years of age.
Documented diagnosis of testosterone deficiency.
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).
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).

Key exclusion criteria (19 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Jatenzo237 mg soft gel capsule taken twice a day by mouth with food.	Drug	Jatenzo Arm

Primary outcome

Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain)
Time frame: 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
Time frame: 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).

4 secondary outcomes

Serum Testosterone Levels
Time frame: Up to 6 months
Serum Estradiol Levels
Time frame: Up to 6 months
Hematocrit Levels
Time frame: Up to 6 months
PSA Levels Measured in ng/mL
Time frame: Up to 6 months

Results and safety

Results posted to the registry on 14 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Jatenzo Arm	41	25

Primary outcome: Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain)

Time frame: Up to 6 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Jatenzo Arm n = 30
Baseline	66.7 (55.3 to 78.1)
Month 3	83.1 (76.8 to 89.3)
Month 6	83.7 (75.5 to 91.9)

Population analysed: Some participants did not complete all of the study visits due to non compliance with the protocol.

Primary outcome: Hypogonadal Symptoms as Measured by qADAM Questionnaire

Time frame: Up to 6 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Jatenzo Arm n = 30
Baseline	36.6 (35.7 to 37.5)
Month 3	34.4 (32.9 to 36.0)
Month 6	35.5 (33.5 to 37.6)

Population analysed: Some participants did not complete all of the study visits due to non compliance with the protocol.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Jatenzo Arm	1 of 41 (2.4%)	5 of 41 (12.2%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Testosterone Deficiency

RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
Not yet recruiting
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
Menopause, Sexual Dysfunction
RecruitingPhase 2
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Metastatic Prostate Cancer
RecruitingObservational study
Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Testosterone Deficiency, Male Hypogonadism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ranjith Ramasamy, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Jatenzo in people with Testosterone Deficiency, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.