Patient Satisfaction After Switching to Oral Testosterone Undecanoate

NCT04983940 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20200971
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Testosterone Deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Serum Testosterone Levels

  Up to 6 months

• Serum Estradiol Levels

  Up to 6 months

• Hematocrit Levels

  Up to 6 months

• PSA Levels Measured in ng/mL

  Up to 6 months

Study Arms (1)

Jatenzo Arm

EXPERIMENTAL

Participants in this group will receive Jatenzo for 26 consecutive weeks.

Drug: Jatenzo

Interventions

Jatenzo DRUG

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

Jatenzo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Clarus Therapeutics, Inc.: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Testosterone Propionate

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Ranjth Ramasamy
• Organization: University of Miami, Miller School of Medicine - Desai Sethi Urology Institute

Ramasamy@miami.edu

305-243-6596

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 30, 2021
• Study Start: June 18, 2021
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: December 14, 2023
• Results First Posted: December 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)