Patient Satisfaction After Switching to Oral Testosterone Undecanoate

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: Completed
• Conditions: Testosterone Deficiency
• Intervention / Treatment: Drug: Jatenzo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Clarus Therapeutics
• Investigators: Principal Investigator: Ranjith Ramasamy, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID 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