HypogonadismPhase 4NCT04274894

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

A Phase 4 study testing AndroGel 1.62% in people with Hypogonadism, run by AbbVie at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypogonadism
What is being tested?: AndroGel 1.62%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 246 participants
Where: 45 sitesUnited States
Study dates: 12 May 2020to 7 Jan 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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).

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

NM Clinical Research & Osteoporosis Center, Inc /ID# 216808
Albuquerque, New Mexico, 87106
Arlington Family Research Center, Inc /ID# 216363
Arlington, Texas, 76012
Randolph Health Internal Medicine /ID# 216366
Asheboro, North Carolina, 27203
Lynn Institute of Denver /ID# 216863
Aurora, Colorado, 80012
Burke Internal Medicine & Research /ID# 216322
Burke, Virginia, 22015-2234
Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362
Canton, Ohio, 44718
OnSite Clinical Solutions, LLC /ID# 216279
Charlotte, North Carolina, 28277
OnSite Clinical Solutions, LLC /ID# 216368
Charlotte, North Carolina, 28277
Loretto Hospital.Affnity Clinical Research Institute /ID# 216884
Chicago, Illinois, 60644
Innovative Research of West Florida /ID# 216364
Clearwater, Florida, 33756-2004
Seidman Clinical Trials,Delray /ID# 216794
Delray Beach, Florida, 33484-6529
Centennial Medical Group /ID# 216340
Elkridge, Maryland, 21075
Investigative Clinical Research of Indiana, LLC /ID# 216943
Elwood, Indiana, 46036-3341
G & L Research, LLC /ID# 216793
Foley, Alabama, 36535
Invesclinic, U.S., LLC /ID# 216778
Fort Lauderdale, Florida, 33308
AccuMed Research Associates /ID# 216775
Garden City, New York, 11530
Triad Clinical Trials /ID# 216792
Greensboro, North Carolina, 27410
Indago Research and Health Cen /ID# 216319
Hialeah, Florida, 33012-4170
Associates in Medicine, P.A. /ID# 216781
Houston, Texas, 77027-3103
Care Partners Clinical Research /ID# 216773
Jacksonville, Florida, 32277
New Phase Research & Development /ID# 216774
Knoxville, Tennessee, 37909
FMC Science /ID# 216318
Lampasas, Texas, 76550
Advanced Biomedical Research of America /ID# 216797
Las Vegas, Nevada, 89123
The Research Grp of Lexington /ID# 216451
Lexington, Kentucky, 40503-2969
Manassas Clinical Research Center /ID# 216313
Manassas, Virginia, 20110-4421
Clinical Neuroscience Solutions - Memphis /ID# 216790
Memphis, Tennessee, 38119
Solaris Clinical Research /ID# 216772
Meridian, Idaho, 83646
Pharmax Research Clinic /ID# 216343
Miami, Florida, 33126
Care Research center Inc. /ID# 216367
Miami, Florida, 33175
Virginia Research Center /ID# 216341
Midlothian, Virginia, 23114-3256
Lucas Research /ID# 216487
Morehead City, North Carolina, 28557
NewportNativeMD, Inc. /ID# 216992
Newport Beach, California, 92663-3600
Intend Research /ID# 216320
Norman, Oklahoma, 73069
Valley Renal Medical Group Research /ID# 216321
Northridge, California, 91324-4622
Affinity Clinical Research /ID# 216807
Oak Brook, Illinois, 60523-1245
West Orange Endocrinology /ID# 217106
Ocoee, Florida, 34761-4547
Tristar Clinical Investigations PC /ID# 216944
Philadelphia, Pennsylvania, 19114-1025
Discovery Clinical Trials-San Antonio /ID# 216866
San Antonio, Texas, 78258
West Coast Research LLC /ID# 216813
San Ramon, California, 94582
Frontier Clinical Research /ID# 216365
Smithfield, Pennsylvania, 15478
Northwest Houston Clinical Research PLLC /ID# 216358
Tomball, Texas, 77375
Amici Clinical Research /ID# 216779
Warren Township, New Jersey, 07059
Iowa Diabetes and Endocrinology Research Center /ID# 216316
West Des Moines, Iowa, 50265
PRN Professional Research Network of Kansas, LLC /ID# 216805
Wichita, Kansas, 67205
North Georgia Clinical Research /ID# 216864
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: 24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy

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 evaluated the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who used testosterone replacement therapy.

AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This was an open-label study which means that both the study doctor and study participants knew what drug and what dose is being used. All participants in this study were in the same group, called a treatment arm. Adult male participants with hypogonadism were enrolled and received AndroGel 1.62%. This was a multi-center study with 190 participants enrolled (initially planned) in approximately 45 sites in the United States to yield 171 subjects in the per protocol (PP) population. A blinded sample size re-estimation (BSSR) was performed when around 70% of the planned subjects in the PP population had completed the end of treatment visit. Sample size was increased at BSSR and 246 participants were actually enrolled.

Participants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.

There may have been a higher burden for participants in this study compared to standard of care. Participants attended 8 study visits during the course of the study at a hospital or clinic and received 2 study phone calls. The effect of the treatment was checked by medical assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure monitors.

Conditions: Hypogonadism
Being tested: AndroGel 1.62%
Keywords: Hypogonadism, Testosterone Replacement Therapy, AndroGel
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AndroGel 1.62%Drug
Also called Testosterone gel
AndroGel 1.62% was packaged in pump bottles with quantities sufficient to accommodate study design and could have been dose adjusted between a minimum of 20.25 mg of T (1 pump actuation) and a maximum of 81.0 mg of testosterone (4 pump actuations). For the first study drug administration at the Day 1 Visit, and also at Week 2, Week 4, Week 16 ambulatory blood pressure monitoring (ABPM,) and End of Treatment Visits, participants applied the study drug while on site so that the site staff could observe the proper administration of study drug. If participants forgot to apply their AndroGel 1.62% dose at their regularly scheduled dosing time, they were to take the next dose at the next dosing time.

Study groups in NCT04274894
Study group	Role	What they receive
AndroGel 1.62%	Experimental	AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study, for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4. Receives: Drug: AndroGel 1.62%

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).
Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 20207 Jan 2022

First posted18 Feb 2020
Study start12 May 2020
Primary completion7 Dec 2021
Study completion7 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypogonadismStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04274894
Sponsor's protocol ID: M19-161
Status last verified: Nov 2022
First submitted: 17 Feb 2020
Last updated: 15 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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, analyses plans, 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.

Publications

Weber MA, Aslam S, Efros MD, Chan A, Khan N, Li X, Dubcenco E, Miller MG. Single-arm study of testosterone gel replacement therapy and ambulatory blood pressure outcomes in men with hypogonadism. Andrology. 2025 Sep;13(6):1390-1401. doi: 10.1111/andr.13779. Epub 2024 Oct 9.
PubMed 39385523

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy
ClinicalTrials.gov ID: NCT04274894
Acronym / sponsor ID: M19-161
Conditions: Hypogonadism
Keywords: Hypogonadism, Testosterone Replacement Therapy, AndroGel
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 12 May 2020 (actual)
Primary completion: 7 Dec 2021 (actual)
Study completion: 7 Jan 2022 (actual)
First posted: 18 Feb 2020 (actual)
Results: Posted 15 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AndroGel 1.62%	Experimental	Drug: AndroGel 1.62%AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study, for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:
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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AndroGel 1.62%Also: Testosterone gelAndroGel 1.62% was packaged in pump bottles with quantities sufficient to accommodate study design and could have been dose adjusted between a minimum of 20.25 mg of T (1 pump actuation) and a maximum of 81.0 mg of testosterone (4 pump actuations). For the first study drug administration at the Day 1 Visit, and also at Week 2, Week 4, Week 16 ambulatory blood pressure monitoring (ABPM,) and End of Treatment Visits, participants applied the study drug while on site so that the site staff could observe the proper administration of study drug. If participants forgot to apply their AndroGel 1.62% dose at their regularly scheduled dosing time, they were to take the next dose at the next dosing time.	Drug	AndroGel 1.62%

Primary outcome

Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 16
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).

Results and safety

Results posted to the registry on 15 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AndroGel 1.62%	246	204

Primary outcome: Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 16. Mean (Standard Deviation). Unit: mmHg

Measure	AndroGel 1.62% n = 169
Value	1.9 (8.99)

AndroGel 1.62%: LS Mean Change from Baseline to EOT: 1.9 (95% CI 0.63 to 3.13)

Population analysed: Per protocol set analysis: all participants who received at least 1 dose of study drug, were at least 85% compliant to study drug, and had valid Baseline and end of treatment systolic ABPM data

Adverse events

Time frame: All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AndroGel 1.62%	8 of 246 (3.3%)	43 of 246 (17.5%)	0 of 246

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39385523Weber MA, Aslam S, Efros MD, Chan A, Khan N, Li X, Dubcenco E, Miller MG. Single-arm study of testosterone gel replacement therapy and ambulatory blood pressure outcomes in men with hypogonadism. Andrology. 2025 Sep;13(6):1390-1401. doi: 10.1111/andr.13779. Epub 2024 Oct 9.
Related Info.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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, analyses plans, 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.

Related trials for Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ABBVIE INC. study director

AbbVie

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AndroGel 1.62% in people with Hypogonadism, run by AbbVie at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP) (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274894, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.