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CompletedNCT04456296Updated Mar 14, 2025Results posted

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

A Phase 4 interventional study of Aveed Injectable Product and Fortesta in Hypogonadism, Hypogonadism, Male and Hypogonadotropic Hypogonadism, sponsored by Endo Pharmaceuticals. Completed at 35 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.

Primary conditionEunuchismRegistry: HypogonadismReclassifiedWhy we changed it
Registry
Hypogonadism — the first condition term the registry derived for this study.
ClinicalTrials.gg
Eunuchism
Why
  1. The study's listed conditions name Eunuchism, a narrower term within Hypogonadism.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
673
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Hypogonadism
  • Hypogonadism, Male
  • Hypogonadotropic Hypogonadism

Browse trials for

03

In context

Eunuchism Reclassified

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 673 is above the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.

Browse Endo Pharmaceuticals studies →All Keenova Therapeutics plc studies →

Compared within Eunuchism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypogonadism. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Have a diagnosis of primary hypogonadism or hypogonadotropic hypogonadism.
  2. 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
  3. Be naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.
  4. 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.
  5. Be judged to be in good health.
  6. 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 .
  7. Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Has a history of significant sensitivity or allergy to the study drugs, including androgens, or product .
  3. 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.
  4. Has changes in any medications (including dosages) or medical conditions in the 28 days prior to screening
  5. Is not on a stable medication regimen for at least 3 months for the treatment of a chronic condition.
  6. Has had a cardiovascular and/or cerebrovascular event within the last 6 months.
  7. Needs blood pressure cuff size larger than 50 centimeters.
  8. Works a night shift or performs heavy manual labor.
  9. Has any known (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.

  10. Uses known inhibitors (for example, ketoconazole) or inducers of cytochrome P450 3A (for example, dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A () within 30 days prior to study drug administration and through the end of the study.

    1. 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.
    2. 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.
    3. Uses nutraceuticals or homeopathic compounds which have a known effect on blood pressure.
  11. Has a history of drug or alcohol abuse within 6 months prior to study drug administration.
  12. Has untreated moderate to severe depression.
  13. Has any skin lesions/cuts/injury at the application site that prohibits topical application and/or intramuscular injection of study drug.
  14. Has suspected reversible hypogonadism.
  15. Donated blood or blood products or experienced significant blood loss within 90 days prior to study drug administration.
  16. Intends to conceive at any time during the study.
  17. Donated bone marrow within 6 months prior to study drug administration.
  18. Has participated in a previous study or received treatment with an investigational product within 30 days of screening.
  19. Has a diagnosis of, is undergoing therapy for, or has received therapy for a hematologic in the 5 years prior to screening.
  20. 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).
  21. Abnormal (ECG) ( with QTc ≥450 milliseconds).
  22. Has evidence of abnormalities on physical examination, vital signs, ECG, or clinical lab values, unless judged to be clinically insignificant by the investigator
  23. Has any other condition that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
673 participants (actual)

Study arms

  • Active comparator
    AVEED (Testosterone Undecanoate Injection)

    Fixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections.

    Drug: Aveed Injectable Product

  • Active comparator
    FORTESTA (Testosterone Gel)

    40 mg once daily topical gel administration.

    Drug: Fortesta

  • Active comparator
    TESTIM (Testosterone Gel)

    50 mg once daily topical gel administration.

    Drug: Testim

Interventions

  • DrugAveed Injectable Product

    Testosterone undecanoate administered by intramuscular injections.

    Also known as: Testosterone undecanoate

  • DrugFortesta

    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).

    Also known as: Testosterone gel

  • DrugTestim

    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).

    Also known as: Testosterone gel

06

What researchers measure

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. 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.

    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

  2. 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.

    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

  3. 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.

    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

  4. 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.

    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

  5. 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.

    Time frame: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms

  6. 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.

    Time frame: EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms

07

Results

Posted Mar 14, 2025

Participant flow

Participant flow — Overall Study
MilestoneAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Started224224225
Safety population222223225
Intent-to-treat (itt) population222223225
Full analysis set140133134
Completed202194192
Not completed223033
Withdrew: Withdrawal by subject142121
Withdrew: Adverse event222
Withdrew: Death100
Withdrew: Lost to follow-up356
Withdrew: Other than specified014
Withdrew: Randomized, not treated210

Outcome measures

PrimaryChange 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.

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
Reported as:
Least squares mean · millimeters of mercury (mmHg)
Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS)
millimeters of mercury (mmHg)AVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS)2.77 (0.95 to 4.59)2.78 (0.86 to 4.69)2.15 (0.28 to 4.03)
SecondaryChange 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.

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
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS
mmHgAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Change From Baseline in 24-Hour Average Mean Arterial Pressure (MAP) to EOS2.13 (0.89 to 3.37)1.78 (0.47 to 3.08)1.21 (-0.06 to 2.49)
SecondaryChange 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.

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
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS
mmHgAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Change From Baseline in 24-Hour Average Diastolic Ambulatory Blood Pressure to EOS1.85 (0.79 to 2.91)1.22 (0.10 to 2.34)0.81 (-0.28 to 1.91)
SecondaryChange 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.

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
Reported as:
Least squares mean · beats per minute
Change From Baseline in 24-Hour Average Heart Rate to EOS
beats per minuteAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Change From Baseline in 24-Hour Average Heart Rate to EOS2.89 (1.47 to 4.31)1.56 (0.07 to 3.06)1.84 (0.37 to 3.31)
SecondaryChange 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.

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
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS
mmHgAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Change From Baseline in 24-Hour Average Pulse Pressure (PP) to EOS0.80 (-0.41 to 2.0)1.49 (0.22 to 2.75)1.40 (0.16 to 2.63)
SecondaryPercentage 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.

Time frame:
EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Reported as:
Number · Percentage of participants
Percentage of Participants Taking New Antihypertensive Medications
Percentage of participantsAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Percentage of Participants Taking New Antihypertensive Medications1.41.52.2
SecondaryPercentage 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.

Time frame:
EOS Visit: up to Day 107 for the Aveed Arm, and up to Day 114 for Fortesta and Testim Arms
Reported as:
Number · Percentage of participants
Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications
Percentage of participantsAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Percentage of Participants With Dose Increase From Baseline in Antihypertensive Medications000

Adverse events

Collected over 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. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AVEED® (Testosterone Undecanoate Injection)1/224 (0.4%)3/222 (1.4%)8/222 (3.6%)
FORTESTA® (Testosterone Gel)0/224 (0%)1/223 (0.4%)9/223 (4%)
TESTIM® (Testosterone Gel)0/225 (0%)2/225 (0.9%)13/225 (5.8%)
Most frequent serious events
Most frequent serious events
EventAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
Myocardial infarctionCardiac disorders1/2220/2230/225
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/2220/2230/225
AngioedemaSkin and subcutaneous tissue disorders1/2220/2230/225
Acute myocardial infarctionCardiac disorders0/2221/2230/225
Acute coronary syndromeCardiac disorders0/2220/2231/225
SepsisInfections and infestations0/2220/2231/225
Cerebrovascular accidentNervous system disorders0/2220/2231/225
Most frequent other events
Most frequent other events
EventAVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)
HypertensionVascular disorders7/2225/2237/225
HeadacheNervous system disorders1/2222/2233/225
Blood testosterone increasedInvestigations0/2222/2233/225

Baseline characteristics

Safety population included all participants who received at least 1 dose/injection of study intervention.

Age, Continuous
Age, Continuous(years)AVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)Total
Mean59.9 ± 10.1056.3 ± 10.7858.4 ± 10.2258.2 ± 10.46
Sex: Female, Male
Sex: Female, Male(Participants)AVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)Total
Female0000
Male222223225670
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)Total
Hispanic or Latino719279242
Not Hispanic or Latino151131146428
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)Total
American Indian or Alaska Native0112
Asian811019
Native Hawaiian or Other Pacific Islander1023
Black or African American374143121
White174179168521
More than one race1113
Unknown or Not Reported1001
24-Hour Average Systolic Ambulatory Blood Pressure
24-Hour Average Systolic Ambulatory Blood Pressure(mmHg)AVEED® (Testosterone Undecanoate Injection)FORTESTA® (Testosterone Gel)TESTIM® (Testosterone Gel)Total
Mean124.90 ± 12.178123.95 ± 11.499124.45 ± 12.505124.43 ± 12.058
08

Study locations

35 sites
  • Endo Clinical Trial Site #8
    Birmingham, Alabama 35235, United States
  • Endo Clinical Trial Site #22
    Tucson, Arizona 85712, United States
  • Endo Clinical Trial Site #15
    North Little Rock, Arkansas 72116, United States
  • Endo Clinical Trial Site #32
    Bell Gardens, California 90201, United States
  • Endo Clinical Trial Site #33
    Canoga Park, California 91304, United States
  • Endo Clinical Trial Site #30
    Beverly Hills, Florida 90211, United States
  • Endo Clinical Trial Site #12
    Boynton Beach, Florida 33435, United States
  • Endo Clinical Trial Site #34
    Boynton Beach, Florida 33435, United States
  • Endo Clinical Trial Site #29
    Fleming Island, Florida 32003, United States
  • Endo Clinical Trial Site #10
    Miami Beach, Florida 33140, United States
  • Endo Clinical Trial Site #18
    Miami Gardens, Florida 33023, United States
  • Endo Clinical Trial Site #26
    Miami, Florida 33014, United States
  • Endo Clinical Trial Site #2
    Miami, Florida 33014, United States
  • Endo Clinical Trial Site #28
    Miami, Florida 33183, United States
  • Endo Clinical Trial Site #3
    Oviedo, Florida 32765, United States
  • Endo Clinical Trial Site #4
    Pembroke Pines, Florida 33027, United States
  • Endo Clinical Trial Site #11
    Pompano Beach, Florida 33060, United States
  • Endo Clinical Trial Site #23
    West Palm Beach, Florida 33401, United States
  • Endo Clinical Trial Site #16
    Chicago, Illinois 60611, United States
  • Endo Clinical Trial Site #27
    Glen Burnie, Maryland 21061, United States
  • Endo Clinical Trial Site #17
    Towson, Maryland 21204, United States
  • Endo Clinical Trial Site #35
    East Orange, New Jersey 07018, United States
  • Endo Clinical Trial Site #9
    Garden City, New York 11530, United States
  • Endo Clinical Trial Site #7
    New York, New York 10016, United States
  • Endo Clinical Trial Site #25
    Winston-Salem, North Carolina 27103, United States
  • Endo Clinical Trial Site #5
    Dayton, Ohio 45417, United States
  • Endo Clinical Trial Site #13
    Bala-Cynwyd, Pennsylvania 19004, United States
  • Endo Clinical Trial Site #19
    Houston, Texas 77036, United States
  • Endo Clinical Trial Site #31
    Houston, Texas 77084, United States
  • Endo Clinical Trial Site #20
    Houston, Texas 77087, United States
  • Endo Clinical Trial Site #21
    Missouri City, Texas 77459, United States
  • Endo Clinical Trial Site #1
    San Antonio, Texas 78229, United States
  • Endo Clinical Trial Site #14
    Rutland, Vermont 05701, United States
  • Endo Clinical Trial Site #6
    Charlottesville, Virginia 22911, United States
  • Endo Clinical Trial Site #24
    Virginia Beach, Virginia 23462, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Jul 2023, 36 months.

Results were first posted in Mar 2025, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2020
First posted
Jul 2, 2020
StartActual
Jun 30, 2020
Primary completionActual
Jul 12, 2023
CompletionActual
Jul 12, 2023
Results first posted
Mar 14, 2025
Last update
Mar 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04456296
Lead sponsor
Endo Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 2, 2020
Start date
Jun 30, 2020
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023
Results posted
Mar 14, 2025
Last update
Mar 14, 2025

Study contacts

David Hernandez
study director · Endo Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Testosterone undecanoate · Testosterone

Other studies in this condition

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Other studies from this sponsor

Endo Pharmaceuticals →

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