Patient Satisfaction After Switching to Oral Testosterone Undecanoate

November 21, 2023 updated by: Ranjith Ramasamy, MD, University of Miami

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Jatenzo Arm
Participants in this group will receive Jatenzo for 26 consecutive weeks.
Drug: Jatenzo
237 mg soft gel capsule taken twice a day by mouth with food.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months
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).
Up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Testosterone Levels
Time Frame: Up to 6 months
Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
Up to 6 months
Serum Estradiol Levels
Time Frame: Up to 6 months
Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw.
Up to 6 months
Hematocrit Levels
Time Frame: Up to 6 months
Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw.
Up to 6 months
PSA Levels Measured in ng/mL
Time Frame: Up to 6 months
Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clarus Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ranjith Ramasamy, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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