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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.

Sponsored by Endo Pharmaceuticals · 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
03

Who can participate

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

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 contraception.
  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 excipients.
  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 clinically significant 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 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.

  10. 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.

    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 investigational 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 malignancy 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 electrocardiogram (ECG) (QT prolongation 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.
04

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

05

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

06

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
07

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
08

References and documents

Study documents

  • Study protocol · Feb 28, 2002
  • Statistical analysis plan · Jan 11, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

09

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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