A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants

A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04320745

Enrollment

168

Registered

2020-03-25

Start date

2020-05-19

Completion date

2021-06-24

Last updated

2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Brief summary

This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in adult hypogonadal men as measured by 24-hour ABPM.

Interventions

DRUGAndroderm®

Androderm® transdermal dose.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (DHEA), including investigational products that may affect the reproductive hormonal system or has not been treated with these compounds in the past 6 months * Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period * Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent * Body mass index (BMI) \< 35 kilograms per metre square (kg/m\^2) * Male

Exclusion criteria

* Uncontrolled systemic disease or clinically significant disease, in particular, liver, kidney or heart disease, including hypertension, congestive heart failure, coronary heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that in the investigator's opinion, would put the participant at an unacceptable risk with exposure to Androderm® * History of prostate (current or in the past) or breast cancer * Had a recent (within 2 years) history of stroke, transient ischemic attack, acute coronary event, venous thrombotic, or thromboembolic event * History of alcohol or other substance abuse within the previous 2 years * Known allergy or sensitivity to the study intervention or its components or other testosterone replacement medications * Participant who works night shifts or who will need to perform strenuous manual labor while wearing the ABPM monitor

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16	Baseline and Week 16	SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.

Secondary

Measure	Time frame	Description
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16	Baseline and Week 16	DBP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16	Baseline and Week 16	MAP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16	Baseline and Week 16	Pulse pressure was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16	Baseline and Week 16	Heart rate was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Androderm® 4 mg Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.	168
Total	168

Arm

Count

Androderm® 4 mg

Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 ng/dL, the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.

168

Total

168

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	26
Overall Study	Lost to Follow-up	12
Overall Study	Non-compliance With Study Drug	2
Overall Study	Protocol Deviation	2
Overall Study	Reason Not Specified	1
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Androderm® 4 mg
Age, Continuous	56.2 years STANDARD_DEVIATION 11.52
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	4 Participants
Race (NIH/OMB) Black or African American	28 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	133 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	168 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 168
other Total, other adverse events	29 / 168
serious Total, serious adverse events	2 / 168

Outcome results

Primary

Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16

SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.