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

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    150
  • sponsor
    Allergan
Updated on 27 January 2021
testosterone
testosterone level
clomiphene

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

Details
Condition Hypogonadism
Treatment Androderm®
Clinical Study IdentifierNCT04320745
SponsorAllergan
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Are you male?
Do you have Hypogonadism?
Do you have any of these conditions: Do you have Hypogonadism??
Do you have any of these conditions: Do you have Hypogonadism??
Do you have any of these conditions: Do you have Hypogonadism??
Nave to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and 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
BMI < 35 kg/m2
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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