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Vogelxo for Low Testosterone
Study Summary
This trial will assess the safety and efficacy of an investigational drug in men with low levels of testosterone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Open-Label
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- 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.
- 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.
Frequently Asked Questions
Could I fulfill the requirements to partake in this investigation?
"This medical trial is looking to recruit 120 individuals aged 18-80 that present symptoms consistent with hypogonadism. The potential participants must meet the following criteria: adult males between ages 18 and 80, not having used testosterone replacements or related products for two months prior, able to properly apply the topical gels specified by staff, and have intact skin on their upper arms/shoulders where these medicines will be applied."
Is this clinical experiment presently accepting participants?
"Affirmative. The details of this clinical trial, which were first posted in August 2020, can be found on the website for clinicaltrials.gov and it is actively looking for participants. A total of 120 patients are needed to participate at 4 different medical centres."
Are there any previous experiments that have been conducted regarding this therapeutic method?
"Initially researched in 2004 at USC/Norris Comprehensive Cancer Center and Hospital, this therapeutic intervention has been subject to 190 studies. Nowadays there are 29 active trials running across the country but particularly concentrated around Garden City, New york."
What clinical conditions have been observed to respond positively to this treatment?
"The preferred treatment for hypogonadotropic hypogonadism is this intervention, which has also been proven to be beneficial in 1-5 year post-menopausal women, those who have undergone orchidectomy and those suffering from orchitis."
Are individuals aged 85 or younger allowed to partake in this experiment?
"The required age range to be included in this trial is 18 and 80 respectively."
How many sites are engaged in running this experiment?
"Four clinical sites have been selected to run this trial - Garden City, North Charleston, San Antonio and additional locations. It is advantageous for participants to choose a site close by in order to reduce the amount of travelling necessary."
How many participants are being recruited for this experiment?
"To complete this clinical trial, 120 qualified patients will have to be enrolled. These participants may come from Upsher-Smith Clinical Trials Site #7 in Garden City, New york and/or the North Charleston, South carolina location (Upsher-Smith Clinical Trials Site #4)."
Are there any adverse effects that may arise from this therapeutic approach?
"There is sufficient evidence to grant this treatment a safety rating of 3, as it has progressed through Phase 4 trials and been approved."
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