Status:
COMPLETED
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Lead Sponsor:
AbbVie
Conditions:
Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexu...
Eligibility Criteria
Inclusion
- Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:
- Decreased sexual desire or libido
- Decreased spontaneous erections (e.g. morning erections)
- Decreased energy or fatigue/feeling tired
- Low mood or depressed mood
- Loss of body (axillary and pubic) hair or reduced shaving
- Hot flashes AND
- Confirmed by 2 serum testosterone levels \< 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.
- Blood pressure \>100/60 mmHg and \<140/90 mmHg
Exclusion
- Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia
- Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease
- Prostate or breast cancer
- Any active malignancy
- Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug
- Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2022
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04274894
Start Date
May 12 2020
End Date
January 7 2022
Last Update
December 15 2022
Active Locations (45)
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1
G & L Research, LLC /ID# 216793
Foley, Alabama, United States, 36535
2
NewportNativeMD, Inc. /ID# 216992
Newport Beach, California, United States, 92663-3600
3
Valley Renal Medical Group Research /ID# 216321
Northridge, California, United States, 91324-4622
4
West Coast Research LLC /ID# 216813
San Ramon, California, United States, 94582