Patient Satisfaction After Switching to Oral Testosterone Undecanoate

Testosterone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983940
• Other study ID #: 20200971
• Status: Completed
• Phase: Phase 4
• Start date: June 18, 2021
• Est. completion date: April 6, 2023

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Testosterone Deficiency

Intervention

Drug:
• Jatenzo
237 mg soft gel capsule taken twice a day by mouth with food.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Clarus Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 6 months
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).	Up to 6 months
Secondary	Serum Testosterone Levels	Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw	Up to 6 months
Secondary	Serum Estradiol Levels	Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw.	Up to 6 months
Secondary	Hematocrit Levels	Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw.	Up to 6 months
Secondary	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