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Testosterone Replacement Therapy
Vogelxo for Low Testosterone
Phase 4
Waitlist Available
Research Sponsored by Upsher-Smith Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Intact skin surfaces on the upper arms and shoulders where the topical testosterone will be applied
Must not have
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
History of prostate (current or in the past) or breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Summary
This trial will assess the safety and efficacy of an investigational drug in men with low levels of testosterone.
Who is the study for?
Men aged 18-80 with low testosterone levels, specifically less than 300 ng/dL on two separate mornings. Participants must be in good health, have intact skin for gel application, and show symptoms of hypogonadism. They should not have used any hormone-related treatments recently and must be willing to follow the study protocol.
What is being tested?
The trial is testing Vogelxo, a topical testosterone gel for men with low testosterone (hypogonadism). It's a Phase 4 study focusing on how the treatment affects blood pressure monitored over a day (ABPM).
What are the potential side effects?
Potential side effects may include skin reactions at the application site, changes in blood pressure or mood swings due to altered hormone levels. Other risks could involve alterations in red blood cell counts or liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My testosterone levels are below 300 ng/dL on two separate morning tests.
Select...
My upper arms and shoulders have healthy skin for testosterone application.
Select...
I am a man aged between 18 and 80.
Select...
My morning testosterone levels were below 300 ng/dL on two separate tests.
Select...
My skin is healthy on my upper arms and shoulders where I'll apply testosterone.
Select...
I am a man aged between 18 and 80.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking a high dose of steroids and have not used opioids recently.
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I have had prostate or breast cancer in the past or currently.
Select...
I haven't changed my blood pressure medication or started any new supplements that could affect my blood pressure in the last 14 days.
Select...
My testosterone levels were below 100 ng/dL twice during screening.
Select...
I have severe urinary problems.
Select...
I haven't taken growth hormone or estrogen treatments in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the 24-hour ABPM average SBP
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-LabelExperimental Treatment1 Intervention
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Who is running the clinical trial?
Upsher-Smith LaboratoriesLead Sponsor
9 Previous Clinical Trials
1,683 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You work night shifts.Your blood pressure is too low (less than 80/50) or too high (more than 150/100) when measured at the screening.I am currently taking a high dose of steroids and have not used opioids recently.I have had prostate or breast cancer in the past or currently.I haven't changed my blood pressure medication or started any new supplements that could affect my blood pressure in the last 14 days.You weigh more than 110 pounds for every 4.5 feet of your height.My testosterone levels were below 100 ng/dL twice during screening.I am willing and able to follow the study's instructions for applying testosterone gel.I haven't used any hormone treatments or related supplements in the last 2 months.I have skin issues or have used steroids on my arms/shoulders, or had tattoo work there.My testosterone levels are below 300 ng/dL on two separate morning tests.I show signs or symptoms that could be due to low testosterone.My upper arms and shoulders have healthy skin for testosterone application.Your HbA1c level is higher than 11% during the screening.I am a man aged between 18 and 80.I am willing and able to follow instructions for applying testosterone gel as part of this study.My morning testosterone levels were below 300 ng/dL on two separate tests.I have severe urinary problems.I haven't taken growth hormone or estrogen treatments in the last 3 months.I have used nicotine products within the last 6 months.I haven't used any hormone treatments or related supplements in the last 2 months.Your prolactin levels are higher than the normal range.My skin is healthy on my upper arms and shoulders where I'll apply testosterone.My overall health is good as confirmed by recent medical exams.My PSA level is above 3.0 ng/mL, or not above 1.5 ng/mL if I'm on 5-alpha reductase inhibitors.Your blood test shows very high hematocrit, liver enzymes, or severe kidney disease.My overall health is good as confirmed by recent medical exams.I am a man aged between 18 and 80.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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