A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
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|ClinicalTrials.gov Identifier: NCT04274894|
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : June 17, 2020
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 sexual characteristics, impaired sexual function and sense of well-being, depressed mood, decreased muscle strength associated with loss of muscle mass and reduced bone mineral density. AndroGel 1.62% has demonstrated its ability to increase total testosterone levels in the blood by absorption of testosterone through the skin when applied topically. This study will evaluate the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who use testosterone replacement therapy.
AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This is an open-label study which means that both the study doctor and study participants will know what drug and what dose is being used. All participants in this study will be in the same group, called a treatment arm. Adult male participants with hypogonadism will be enrolled and receive AndroGel 1.62%. This is a multi-center study with around 190 participants enrolled in approximately 45 sites in the United States.
Participants will receive daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.
There will be a higher burden for participants in this study compared to standard of care. Participants will attend 8 study visits during the course of the study at a hospital or clinic and receive 2 study phone calls. The effect of the treatment will be checked by medical assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure monitors.
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: AndroGel 1.62%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy|
|Actual Study Start Date :||February 24, 2020|
|Estimated Primary Completion Date :||December 17, 2020|
|Estimated Study Completion Date :||March 15, 2021|
Participants will receive AndroGel 1.62% once daily
Drug: AndroGel 1.62%
Other Name: Testosterone Gel
- Change from Baseline to end of treatment in 24-hour Average Systolic Blood Pressure (SBP) [ Time Frame: Up to Approximately Week 16 ]Change in 24-hour Average Systolic Blood Pressure (SBP) will be assessed for participants using AndroGel as labelled.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274894
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||AbbVie Inc.||AbbVie|