Hypogonadism, MalePhase 4NCT04558567
Vogelxo(R) ABPM Study in Hypogandal Men
A Phase 4 study testing Vogelxo in people with Hypogonadism, Male, run by Upsher-Smith Laboratories at 7 sites in United States.
Trial summary
A Phase 4 ABPM study in Hypogonadal Men Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- Vogelxo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2020to 11 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
- Clinical laboratory analysis shows any of the following abnormal results:
- Hematocrit > 50%
- Alanine aminotransferase or aspartate aminotransferase > 3 × ULN
- Severe or end-stage chronic kidney disease documented by eGFR < 30 mL/min.
- Subject works night shifts.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Upsher-Smith Clinical Trial Site #2
Anaheim, California, 92801
Upsher-Smith Clinical Trial Site #6
Birmingham, Alabama, 35235
Upsher-Smith Clinical Trials Site #7
Garden City, New York, 11530
Upsher-Smith Clinical Trial Site #1
Miami, Florida, 33153
Upsher-Smith Clinical Trials Site #4
North Charleston, South Carolina, 29405
Upsher-Smith Clinical Trials Site #5
San Antonio, Texas, 78229
Upsher-Smith Clinical Trials Site #8
San Antonio, Texas, 78744
About this study
Official title: A Phase 4, Open-Label, Single-Arm Study to Evaluate the Effects of Vogelxo(R) on 24-hour Ambulatory Blood Pressure Monitoring in Hypogonadal Men Using Therapeutic Testosterone Replacement Therapy
A Phase 4 ABPM study in Hypogonadal Men
Read the detailed description
A single-arm, open-label, uncontrolled study consisting of a 4-week screening phase, 4-week titration phase, and 16-week treatment phase.
- Conditions
- Hypogonadism, Male
- Being tested
- Vogelxo
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VogelxoDrug
50mg (1 tube, 5g gel) to 100mg (2 tubes, 10g gel)
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Other | Not described Receives: Drug: Vogelxo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Secondary outcomes (2)
Change from baseline in 24-hour average diastolic blood pressure (DBP)
Measured: 20 weeks
Change from baseline in 24-hour average heart rate (HR)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start28 Aug 2020
- Primary completion12 Dec 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upsher-Smith Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558567
- Sponsor's protocol ID
- P361-502
- Status last verified
- Oct 2024
- First submitted
- 15 Sep 2020
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Single-Arm Study to Evaluate the Effects of Vogelxo(R) on 24-hour Ambulatory Blood Pressure Monitoring in Hypogonadal Men Using Therapeutic Testosterone Replacement Therapy
- ClinicalTrials.gov ID
- NCT04558567
- Acronym / sponsor ID
- P361-502
- Conditions
- Hypogonadism, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Upsher-Smith LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 4 ABPM study in Hypogonadal Men
Detailed description
A single-arm, open-label, uncontrolled study consisting of a 4-week screening phase, 4-week titration phase, and 16-week treatment phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Other | Drug: Vogelxo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Vogelxo50mg (1 tube, 5g gel) to 100mg (2 tubes, 10g gel) | Drug | Open-Label |
Primary outcome
Change from baseline in the 24-hour ABPM average SBP
Time frame: 20 weeks
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.
2 secondary outcomes
Change from baseline in 24-hour average diastolic blood pressure (DBP)
Time frame: 20 weeks
Change from baseline in 24-hour average heart rate (HR)
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 Vogelxo in people with Hypogonadism, Male, run by Upsher-Smith Laboratories at 7 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 8 inclusion and 21 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the 24-hour ABPM average SBP (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.