Trial Outcomes & Findings for Patient Satisfaction After Switching to Oral Testosterone Undecanoate (NCT NCT04983940)

NCT ID: NCT04983940

Last Updated: 2023-12-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2023-12-14

Participant Flow

Participant milestones

Measure	Jatenzo Arm Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Overall Study STARTED	41
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Jatenzo Arm Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Overall Study Lost to Follow-up	14
Overall Study Lack of Efficacy	2

Baseline Characteristics

Patient Satisfaction After Switching to Oral Testosterone Undecanoate

Baseline characteristics by cohort

Measure	Jatenzo Arm n=41 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Age, Continuous	50.8 years STANDARD_DEVIATION 11.9 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	41 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 6 months

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

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.

Outcome measures

Measure	Jatenzo Arm n=30 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) Baseline	66.7 score on a scale Interval 55.3 to 78.1
Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) Month 3	83.1 score on a scale Interval 76.8 to 89.3
Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain) Month 6	83.7 score on a scale Interval 75.5 to 91.9

PRIMARY outcome

Timeframe: Up to 6 months

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

Quantitative Androgen Deficiency in the Aging Male (qADAM) has a total score ranges between 10 (most symptomatic) and 50 (least symptomatic).

Outcome measures

Measure	Jatenzo Arm n=30 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Hypogonadal Symptoms as Measured by qADAM Questionnaire Baseline	36.6 score on a scale Interval 35.7 to 37.5
Hypogonadal Symptoms as Measured by qADAM Questionnaire Month 3	34.4 score on a scale Interval 32.9 to 36.0
Hypogonadal Symptoms as Measured by qADAM Questionnaire Month 6	35.5 score on a scale Interval 33.5 to 37.6

SECONDARY outcome

Timeframe: Up to 6 months

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

Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw

Outcome measures

Measure	Jatenzo Arm n=30 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Serum Testosterone Levels Baseline	200.3 ng/dL Interval 177.7 to 222.9
Serum Testosterone Levels Month 3	486.8 ng/dL Interval 398.9 to 574.7
Serum Testosterone Levels Month 6	649.3 ng/dL Interval 504.0 to 794.7

SECONDARY outcome

Timeframe: Up to 6 months

Population: Estradiol was added to the protocol during an amendment after the trial had begun. Some participants did not complete all of the study visits due to non-compliance with the protocol.

Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw.

Outcome measures

Measure	Jatenzo Arm n=23 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Serum Estradiol Levels Baseline	14.4 pg/mL Interval 11.0 to 17.8
Serum Estradiol Levels Month 3	21.6 pg/mL Interval 16.9 to 26.3
Serum Estradiol Levels Month 6	21.2 pg/mL Interval 15.8 to 26.7

SECONDARY outcome

Timeframe: Up to 6 months

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

Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw.

Outcome measures

Measure	Jatenzo Arm n=30 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Hematocrit Levels Baseline	44.9 percentage of hematocrit Interval 43.5 to 46.4
Hematocrit Levels Month 3	45 percentage of hematocrit Interval 43.6 to 46.5
Hematocrit Levels Month 6	45.2 percentage of hematocrit Interval 43.9 to 46.5

SECONDARY outcome

Timeframe: Up to 6 months

Population: PSA was added to the protocol during an amendment after the trial had begun. Some participants did not complete all of the study visits due to non-compliance with the protocol.

Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw.

Outcome measures

Measure	Jatenzo Arm n=23 Participants Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
PSA Levels Measured in ng/mL Baseline	1.06 ng/mL Interval 0.71 to 1.41
PSA Levels Measured in ng/mL Month 3	1.14 ng/mL Interval 0.8 to 1.49
PSA Levels Measured in ng/mL Month 6	0.95 ng/mL Interval 0.53 to 1.37

Adverse Events

Jatenzo Arm

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Jatenzo Arm n=41 participants at risk Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Renal and urinary disorders Chronic Kidney Disease	2.4% 1/41 • Number of events 1 • 6 months

Other adverse events

Measure	Jatenzo Arm n=41 participants at risk Participants in this group will receive Jatenzo for 26 consecutive weeks. Jatenzo: 237 mg soft gel capsule taken twice a day by mouth with food.
Vascular disorders Hypertension	7.3% 3/41 • Number of events 3 • 6 months
Blood and lymphatic system disorders Polycythemia	2.4% 1/41 • Number of events 1 • 6 months
Renal and urinary disorders Nocturia	2.4% 1/41 • Number of events 1 • 6 months

Additional Information

Dr. Ranjth Ramasamy

University of Miami, Miller School of Medicine - Desai Sethi Urology Institute

Phone: 305-243-6596

Email: Ramasamy@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place