HypogonadismPhase 4NCT04320745

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

A Phase 4 study testing Androderm® in people with Hypogonadism, run by Allergan at 41 sites in United States.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Hypogonadism
What is being tested?: Androderm®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 41 sitesUnited States
Study dates: 19 May 2020to 24 Jun 2021
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 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (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
Body mass index (BMI) < 35 kilograms per metre square (kg/m^2)
Male

Who cannot join

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

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes & Endocrinology
Austin, Texas, 78731
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
South Florida Medical Research
Aventura, Florida, 33180
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Hope Clinical Research
Canoga Park, California, 91303
Columbus Regional Research Institute
Columbus, Georgia, 31904
Creekside Endocrine Associates, PC
Denver, Colorado, 80246
Premier Urology Group
Edison, New Jersey, 08837
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935
AccuMed Research Associates
Garden City, New York, 11530
Marvel Clinical Research
Huntington Beach, California, 92647
San Diego Clinical Trials
La Mesa, California, 91942
WR - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89113
Physicians Research Associates, LLC
Lawrenceville, Georgia, 30046
Idoho Urologic Institute
Meridian, Idaho, 83642
SMS Clinical Research, LLC2
Mesquite, Texas, 75149
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, 36608
DelRicht Research, LLC
New Orleans, Louisiana, 70115
Manhattan Medical Research Practice, PLLC
New York, New York, 10016
Endocrine Consultants Newnan
Newnan, Georgia, 30265
Renstar Medical Research
Ocala, Florida, 34471
Ovieo Medical Research, LLC
Oviedo, Florida, 32765
AIM Trials, LLC
Plano, Texas, 75093
Associated Urologist of North Carolina
Raleigh, North Carolina, 27612
Rainier Clinical Research Center, Inc
Renton, Washington, 98057
Virginia Urology
Richmond, Virginia, 23235
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Wr-McCr, Llc
San Diego, California, 92103
Care Access Research
Santa Clarita, California, 91321
Regional Urology, LLC
Shreveport, Louisiana, 71106
Meridien Research
St. Petersburg, Florida, 33709
Precision Clinical Research, LLC
Sunrise, Florida, 33351
Florida Urology Partners
Tampa, Florida, 33615
Urological Associates of South Arizona, PC
Tucson, Arizona, 85712
Urology of Virginia
Virginia Beach, Virginia, 23462
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02427
The Iowa Clinic
West Des Moines, Iowa, 50266
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men

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.

Conditions: Hypogonadism
Being tested: Androderm®
Medical subject headings: Hypogonadism

What participants receive

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

Androderm®Drug
Androderm® transdermal dose.

Study groups in NCT04320745
Study group	Role	What they receive
Androderm® 4 mg	Experimental	Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range. Receives: Drug: Androderm®

What is being measured

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

Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Measured: Baseline and Week 16

Secondary outcomes (4)

Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
DBP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Measured: Baseline and Week 16
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
MAP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Measured: Baseline and Week 16
Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
Pulse pressure was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Measured: Baseline and Week 16
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Heart rate was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Measured: Baseline and Week 16

Timeline

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

19 May 202024 Jun 2021

First posted25 Mar 2020
Study start19 May 2020
Primary completion24 Jun 2021
Study completion24 Jun 2021

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.
Other trials for HypogonadismStudies of the same condition, open and under way.
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: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04320745
Sponsor's protocol ID: 3146-402-016
Status last verified: Jun 2022
First submitted: 23 Mar 2020
Last updated: 12 Jul 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 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.

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

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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men
ClinicalTrials.gov ID: NCT04320745
Acronym / sponsor ID: 3146-402-016
Conditions: Hypogonadism
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 19 May 2020 (actual)
Primary completion: 24 Jun 2021 (actual)
Study completion: 24 Jun 2021 (actual)
First posted: 25 Mar 2020 (actual)
Results: Posted 12 Jul 2022

Clinical summary

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

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.

Study design

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

Arm	Type	Receives
Androderm® 4 mg	Experimental	Drug: Androderm®Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (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
Body mass index (BMI) < 35 kilograms per metre square (kg/m^2)
Male

Key exclusion criteria (6 listed)

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

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
Androderm®Androderm® transdermal dose.	Drug	Androderm® 4 mg

Primary outcome

Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
Time frame: Baseline and Week 16
SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.

4 secondary outcomes

Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
Time frame: Baseline and Week 16
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
Time frame: Baseline and Week 16
Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
Time frame: Baseline and Week 16
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Time frame: Baseline and Week 16

Results and safety

Results posted to the registry on 12 Jul 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
Androderm® 4 mg	168	121

Primary outcome: Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16

Time frame: Baseline and Week 16. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Androderm® 4 mg n = 62
Baseline	123.2 (11.86)
Change from Baseline at Week 16	3.5 (8.93)

Population analysed: Modified Intent-to-treat (mITT) Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Androderm® 4 mg	2 of 168 (1.2%)	29 of 168 (17.3%)	0 of 168

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink 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 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.

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Not yet recruitingObservational study
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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.

Anna Chan study director

Allergan

41 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 Androderm® in people with Hypogonadism, run by Allergan at 41 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 5 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 12 Jul 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 in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16 (time frame: Baseline and 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 NCT04320745.

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 12 Jul 2022.