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A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04274894
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: AndroGel
Participants will receive AndroGel 1.62% once daily
Drug: AndroGel 1.62%
Topical Gel
Other Name: Testosterone Gel




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 >100/70 mmHg and <140/90 mmHg.

Exclusion Criteria:

  • 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 not otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).

Information from the National Library of Medicine

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 45 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04274894    
Other Study ID Numbers: M19-161
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Hypogonadism
Testosterone Replacement Therapy
AndroGel
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs