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OpenTrials
Completed

NCT Number: NCT04320745

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Central Research Associates, Inc., Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Androderm®

Drug

Androderm® transdermal dose.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16

    Time frame: 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.

  2. Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16

    Time frame: 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.

  3. Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16

    Time frame: 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.

  4. Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2020
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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