HypogonadismPhase 4NCT04456296

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

A Phase 4 study testing Aveed Injectable Product, Fortesta and Testim in people with Hypogonadism and Hypogonadism, Male, run by Endo USA Inc., a Keenova Therapeutics Company at 35 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
What is being tested?: Aveed Injectable Product, Fortesta and Testim
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 673 participants
Where: 35 sitesUnited States
Study dates: 30 Jun 2020to 12 Jul 2023
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

Have a diagnosis of primary hypogonadism or hypogonadotropic hypogonadism.
Have a total serum testosterone at screening < 300 ng/dL based on 2 blood samples obtained at 10 am (+/-2 hours) on 2 separate occasions at least 48 hours apart
Be naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.
Have a screening blood pressure at rest of less than 140 millimeters of mercury (mm Hg) for systolic blood pressure and less than 90 mm Hg for diastolic blood pressure.
Be judged to be in good health.
Participants enrolled in the Testim or Fortesta treatment arms: participants agree to take necessary precautions to avoid skin-to-skin contact and potential transfer and if male use effective contraception.
Be willing and able to cooperate with the requirements of the study.

Who cannot join

Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Has a history of significant sensitivity or allergy to the study drugs, including androgens, or product excipients.
Has a history of or medical examination findings renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric conditions, cardiovascular disease/dysrhythmia) or any other condition(s) that restricts study participation.
Has clinically significant changes in any medications (including dosages) or medical conditions in the 28 days prior to screening
Is not on a stable medication regimen for at least 3 months for the treatment of a chronic condition.
Has had a cardiovascular and/or cerebrovascular event within the last 6 months.

Show all 26Show fewer

Needs blood pressure cuff size larger than 50 centimeters.
Works a night shift or performs heavy manual labor.
Has any known contraindication(s) to active study treatment including, but not limited to: known or suspected carcinoma of the prostate or breast, previous history of cancer (except basal cell carcinoma of the skin) liver disease, active deep vein thrombosis, atrial fibrillation, untreated sleep apnea, or is immune compromised.
Uses known inhibitors (for example, ketoconazole) or inducers of cytochrome P450 3A (for example, dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study.
Uses any of the above listed drugs within 5 half lives of the last dose in the past 6 months prior to study drug administration.
Has received any of the above listed drugs by injection within 30 days or 10 half lives (whichever is longer) prior to study drug administration.
Uses nutraceuticals or homeopathic compounds which have a known effect on blood pressure.
Has a history of drug or alcohol abuse within 6 months prior to study drug administration.
Has untreated moderate to severe depression.
Has any skin lesions/cuts/injury at the application site that prohibits topical application and/or intramuscular injection of study drug.
Has suspected reversible hypogonadism.
Donated blood or blood products or experienced significant blood loss within 90 days prior to study drug administration.
Intends to conceive at any time during the study.
Donated bone marrow within 6 months prior to study drug administration.
Has participated in a previous investigational study or received treatment with an investigational product within 30 days of screening.
Has a diagnosis of, is undergoing therapy for, or has received therapy for a hematologic malignancy in the 5 years prior to screening.
Has a history of substance abuse or is taking any substance of abuse (Note: participants on a stable dose of any medications that have been prescribed by a healthcare practitioner for a properly documented medical condition are exempt).
Abnormal electrocardiogram (ECG) (QT prolongation with QTc ≥450 milliseconds).
Has evidence of abnormalities on physical examination, vital signs, ECG, or clinical lab values, unless judged to be clinically insignificant by the investigator
Has any other condition that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Endo Clinical Trial Site #13
Bala-Cynwyd, Pennsylvania, 19004
Endo Clinical Trial Site #32
Bell Gardens, California, 90201
Endo Clinical Trial Site #30
Beverly Hills, Florida, 90211
Endo Clinical Trial Site #8
Birmingham, Alabama, 35235
Endo Clinical Trial Site #12
Boynton Beach, Florida, 33435
Endo Clinical Trial Site #34
Boynton Beach, Florida, 33435
Endo Clinical Trial Site #33
Canoga Park, California, 91304
Endo Clinical Trial Site #6
Charlottesville, Virginia, 22911
Endo Clinical Trial Site #16
Chicago, Illinois, 60611
Endo Clinical Trial Site #5
Dayton, Ohio, 45417
Endo Clinical Trial Site #35
East Orange, New Jersey, 07018
Endo Clinical Trial Site #29
Fleming Island, Florida, 32003
Endo Clinical Trial Site #9
Garden City, New York, 11530
Endo Clinical Trial Site #27
Glen Burnie, Maryland, 21061
Endo Clinical Trial Site #19
Houston, Texas, 77036
Endo Clinical Trial Site #31
Houston, Texas, 77084
Endo Clinical Trial Site #20
Houston, Texas, 77087
Endo Clinical Trial Site #26
Miami, Florida, 33014
Endo Clinical Trial Site #2
Miami, Florida, 33014
Endo Clinical Trial Site #28
Miami, Florida, 33183
Endo Clinical Trial Site #10
Miami Beach, Florida, 33140
Endo Clinical Trial Site #18
Miami Gardens, Florida, 33023
Endo Clinical Trial Site #21
Missouri City, Texas, 77459
Endo Clinical Trial Site #7
New York, New York, 10016
Endo Clinical Trial Site #15
North Little Rock, Arkansas, 72116
Endo Clinical Trial Site #3
Oviedo, Florida, 32765
Endo Clinical Trial Site #4
Pembroke Pines, Florida, 33027
Endo Clinical Trial Site #11
Pompano Beach, Florida, 33060
Endo Clinical Trial Site #14
Rutland, Vermont, 05701
Endo Clinical Trial Site #1
San Antonio, Texas, 78229
Endo Clinical Trial Site #17
Towson, Maryland, 21204
Endo Clinical Trial Site #22
Tucson, Arizona, 85712
Endo Clinical Trial Site #24
Virginia Beach, Virginia, 23462
Endo Clinical Trial Site #23
West Palm Beach, Florida, 33401
Endo Clinical Trial Site #25
Winston-Salem, North Carolina, 27103

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About this study

Official title: An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Treatment With Marketed Testosterone Products

Testosterone is the principal androgen produced by the male testes. Male Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of testosterone of < 300 nanograms (ng)/deciliters (dL), with no discernible diurnal pattern. The etiology of hypogonadism may be primary or secondary. The treatment of males with primary, and in some cases, secondary hypogonadism includes administration of testosterone.

Testim® and Fortesta® are topical gels that when applied daily help to increase the total testosterone levels in the blood through skin absorption. Aveed® is an injectable form of testosterone treatment and participants randomized to this treatment arm will receive 3 injections over the course of 16 weeks.

This study is designed to evaluate the effect on blood pressure of approved testosterone products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour ambulatory blood pressure to reveal shifts in blood pressure levels.

Conditions: Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
Being tested: Aveed Injectable Product, Fortesta, Testim
Medical subject headings: Hypogonadism, Eunuchism

What participants receive

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

Aveed Injectable ProductDrug
Also called Testosterone undecanoate
Testosterone undecanoate administered by intramuscular injections.
FortestaDrug
Also called Testosterone gel
Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).
TestimDrug
Also called Testosterone gel
Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).

Study groups in NCT04456296
Study group	Role	What they receive
AVEED (Testosterone Undecanoate Injection)	Active comparator	Fixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections. Receives: Drug: Aveed Injectable Product
FORTESTA (Testosterone Gel)	Active comparator	40 mg once daily topical gel administration. Receives: Drug: Fortesta
TESTIM (Testosterone Gel)	Active comparator	50 mg once daily topical gel administration. Receives: Drug: Testim

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 Ambulatory Blood Pressure to End of Study (EOS)
The mean change from Baseline to EOS in 24-hour average systolic ambulatory blood pressure, for each treatment group was analyzed using an analysis of covariance (ANCOVA) model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average systolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Measured: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms

Secondary outcomes (6)

Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS
The mean change from Baseline to EOS in 24-hour MAP, for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour MAP as covariate.EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Measured: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS
The mean change from Baseline to EOS in 24-hour average diastolic ambulatory blood pressure, for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average diastolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Measured: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Change From Baseline in 24-Hour Average Heart Rate to EOS
The mean change from Baseline to EOS in 24-hour average heart rate, for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average heart rate as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Measured: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS
The mean change from Baseline to EOS in 24-hour average PP for each treatment group was analyzed using an ANCOVA model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average PP as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Measured: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Percentage of Participants Taking New Antihypertensive Medications
A new antihypertensive medication was any antihypertensive medication taken on or after the screening Visit through the EOS visit and not taken prior to the screening visit.
Measured: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications
A new antihypertensive medication was any antihypertensive medication taken on or after the screening Visit through the EOS visit and not taken prior to the screening visit.
Measured: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms

Timeline

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

30 Jun 202012 Jul 2023

First posted2 Jul 2020
Study start30 Jun 2020
Primary completion12 Jul 2023
Study completion12 Jul 2023

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 673 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04456296
Sponsor's protocol ID: EN3000-101
Status last verified: Mar 2025
First submitted: 30 Jun 2020
Last updated: 14 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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
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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Treatment With Marketed Testosterone Products
ClinicalTrials.gov ID: NCT04456296
Acronym / sponsor ID: EN3000-101
Conditions: Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 673 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: 30 Jun 2020 (actual)
Primary completion: 12 Jul 2023 (actual)
Study completion: 12 Jul 2023 (actual)
First posted: 2 Jul 2020 (actual)
Results: Posted 14 Mar 2025

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
AVEED (Testosterone Undecanoate Injection)	Active comparator	Drug: Aveed Injectable ProductFixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections.
FORTESTA (Testosterone Gel)	Active comparator	Drug: Fortesta40 mg once daily topical gel administration.
TESTIM (Testosterone Gel)	Active comparator	Drug: Testim50 mg once daily topical gel administration.

Who may qualify

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

Key inclusion criteria (7 listed)

Have a diagnosis of primary hypogonadism or hypogonadotropic hypogonadism.
Have a total serum testosterone at screening < 300 ng/dL based on 2 blood samples obtained at 10 am (+/-2 hours) on 2 separate occasions at least 48 hours apart
Be naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.
Have a screening blood pressure at rest of less than 140 millimeters of mercury (mm Hg) for systolic blood pressure and less than 90 mm Hg for diastolic blood pressure.
Be judged to be in good health.

Key exclusion criteria (26 listed)

Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Has a history of significant sensitivity or allergy to the study drugs, including androgens, or product excipients.
Has a history of or medical examination findings renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric conditions, cardiovascular disease/dysrhythmia) or any other condition(s) that restricts study participation.
Has clinically significant changes in any medications (including dosages) or medical conditions in the 28 days prior to screening
Is not on a stable medication regimen for at least 3 months for the treatment of a chronic condition.

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
Aveed Injectable ProductAlso: Testosterone undecanoateTestosterone undecanoate administered by intramuscular injections.	Drug	AVEED (Testosterone Undecanoate Injection)
FortestaAlso: Testosterone gelTestosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).	Drug	FORTESTA (Testosterone Gel)
TestimAlso: Testosterone gelTestosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).	Drug	TESTIM (Testosterone Gel)

Primary outcome

Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS)
Time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
The mean change from Baseline to EOS in 24-hour average systolic ambulatory blood pressure, for each treatment group was analyzed using an analysis of covariance (ANCOVA) model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average systolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.

6 secondary outcomes

Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS
Time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS
Time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Change From Baseline in 24-Hour Average Heart Rate to EOS
Time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS
Time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Percentage of Participants Taking New Antihypertensive Medications
Time frame: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications
Time frame: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms

Results and safety

Results posted to the registry on 14 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AVEED® (Testosterone Undecanoate Injection)	224	202
FORTESTA® (Testosterone Gel)	224	194
TESTIM® (Testosterone Gel)	225	192

Primary outcome: Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS)

Time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms. Least squares mean (95% Confidence Interval). Unit: millimeters of mercury (mmHg)

Measure	AVEED® (Testosterone Undecanoate Injection) n = 140	FORTESTA® (Testosterone Gel) n = 133	TESTIM® (Testosterone Gel) n = 134
Value	2.77 (0.95 to 4.59)	2.78 (0.86 to 4.69)	2.15 (0.28 to 4.03)

Population analysed: Full analysis set included all ITT participants with valid Baseline and EOS ABPM assessments.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day 1) up to EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AVEED® (Testosterone Undecanoate Injection)	3 of 222 (1.4%)	8 of 222 (3.6%)	1 of 224
FORTESTA® (Testosterone Gel)	1 of 223 (0.4%)	9 of 223 (4%)	0 of 224
TESTIM® (Testosterone Gel)	2 of 225 (0.9%)	13 of 225 (5.8%)	0 of 225

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
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52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
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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.

David Hernandez study director

Endo USA Inc., a Keenova Therapeutics Company

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 26 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 14 Mar 2025). 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 Ambulatory Blood Pressure to End of Study (EOS) (time frame: Baseline (Day 1), EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms). 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 NCT04456296.

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 14 Mar 2025.