Vogelxo(R) ABPM Study in Hypogandal Men

NCT04558567 | Completed Phase 4 FDA Drug

• 1 other identifier: P361-502
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 7

Brief Summary

A Phase 4 ABPM study in Hypogonadal Men

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the 24-hour ABPM average SBP

  Average SBP will be calculated from ABPM measurements taken twice each hour over the 24-hour period. An ABPM measurement session will be standardized and performed during on-site clinic visits at baseline (before treatment) and on the last day of treatment (week 20) to minimize subject variability.

  20 weeks

Secondary Outcomes (2)

• Change from baseline in 24-hour average diastolic blood pressure (DBP)

  20 weeks

• Change from baseline in 24-hour average heart rate (HR)

  20 weeks

Study Arms (1)

Open-Label

OTHER

Drug: Vogelxo

Interventions

Vogelxo DRUG

50mg (1 tube, 5g gel) to 100mg (2 tubes, 10g gel)

Open-Label

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male whose age is between 18 and 80 years, inclusive, at the time of screening.
• Considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
• Meets the study definition of clinical hypogonadism, as evidenced by serum testosterone concentrations:
• Two serum testosterone concentrations \< 300 ng/dL collected in the morning (between 0630 hours and 1000 hours local time) on at least 2 days separated by a minimum of 48 hours.
• Presence of at least 1 sign or symptom that may be related to low testosterone values and is/are consistent with hypogonadism
• Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives and dehydroepiandrosterone, including investigational products that may affect the reproductive hormonal system within the past 2 months.
• Willingness and the ability to apply topical testosterone gel as instructed by the study staff and comply with the requirements of this study protocol.
• Intact skin surfaces on the upper arms and shoulders where the topical testosterone will be applied.

You may not qualify if:

• Two testosterone concentrations \< 100 ng/dL during screening.
• Prolactin concentration \> 1 x upper limit of normal (ULN).
• Current or recurrent ulcer, erosion, lichenification, inflammation psoriasis, eczema or use of topical corticosteroids on the upper arms and shoulders. Tattoo application or removal in the region of study drug application.
• Known skin intolerance to alcohol or allergy to any of the ingredients of the study drug.
• History of treatment with growth hormone, anti-estrogen or estrogen treatment within 90 days prior to screening.
• Currently taking glucocorticoids \> 7.5 mg prednisone equivalent per day (eg, hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) for 1 week before SV1 and through Day 1, and any use of opioids within 5 half-lives prior to Day 1.
• Currently taking, unstable doses within 14 days prior to first administration of study drug or anticipated to receive any antihypertensive medications, over-the-counter medications, supplements or herbal medicines known to affect blood pressure during study participation. These medications or supplements include diet pills (eg, phenylpropanolamine, sibutramine), nasal decongestants (eg, phenylephrine hydrochloride, pseudoephedrine, naphazoline hydrochloride), certain stimulants (eg, amphetamine, methylphenidate dexmethylphenidate, dextroamphetamine), monoamine oxidase inhibitors (MAO), atypical antipsychotics (eg, clozapine, olanzapine).
• History of prostate (current or in the past) or breast cancer.
• Severe lower urinary tract symptoms as indicated by an International Prostate Symptom Score (I-PSS) \> 19.
• Prostate-specific antigen (PSA) \> 3.0 ng/mL; men treated with 5-alpha reductase inhibitors (eg, dutasteride, finasteride) are eligible for participation as long as PSA levels are not \> 1.5 ng/mL.
• Body mass index \> 50 kg/m2.
• Sitting SBP \< 80 mm Hg and \> 150 mm Hg or sitting DBP \< 50 mm Hg and \> 100 mm Hg at any point during screening.
• HbA1c \> 11% at screening.
• A current condition, therapy, laboratory abnormality, history of clinically significant medical or psychiatric conditions or other circumstance or reasons which, in the opinion of the investigator or the study staff, might pose a risk to the subject, make participation not in the subject's best interest, confound the results of the study (eg, if subject cannot comply with requirements of the study), make the subject an unsuitable candidate to receive study drug, or interfere with the subject's participation for the full duration of the study.
• History, suspicion, or evidence of significant drug or alcohol abuse or illicit steroid use within the previous 12 months prior to screening, as determined by the investigator.

Sponsors & Collaborators

• Upsher-Smith Laboratories: lead

Study Sites (7)

Upsher-Smith Clinical Trial Site #6

Birmingham, Alabama, 35235, United States

Location

Upsher-Smith Clinical Trial Site #2

Anaheim, California, 92801, United States

Location

Upsher-Smith Clinical Trial Site #1

Miami, Florida, 33153, United States

Location

Upsher-Smith Clinical Trials Site #7

Garden City, New York, 11530, United States

Location

Upsher-Smith Clinical Trials Site #4

North Charleston, South Carolina, 29405, United States

Location

Upsher-Smith Clinical Trials Site #5

San Antonio, Texas, 78229, United States

Location

Upsher-Smith Clinical Trials Site #8

San Antonio, Texas, 78744, United States

Location

MeSH Terms

Conditions

Eunuchism

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: August 28, 2020
• Primary Completion: December 12, 2023
• Study Completion: January 11, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

US (7)