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Oral Testosterone Therapy for Low Testosterone
Study Summary
This trial will compare patient satisfaction with Jatenzo, an oral testosterone medication, to other forms of testosterone therapy.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 4 trial • 41 Patients • NCT04983940Trial Design
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- You have a severe condition called obstructive sleep apnea that has not been treated.You have a history of drug or alcohol abuse within the last 2 years as determined by the investigator.The researcher or the doctor in charge thinks that Jatenzo is not a suitable treatment for you, for any reason.You have a history of seizures or convulsions, including those caused by fever, alcohol, or drug withdrawal.You have had a severe allergic reaction to androgens or other ingredients in the medication.You have a history of or currently have prostate or breast cancer or are suspected to have it.Your pre-study medical exams found concerning results, such as abnormal breast exam or ECG, that require further evaluation.
- Group 1: Jatenzo Arm
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities for enrolment in this clinical investigation?
"This scientific trial is no longer accepting new volunteers. The experiment was first advertised on June 18th 2021 and the latest update occurred November 7th 2022. If you are still looking for a clinical trial, there are presently 6 studies recruiting people with testosterone deficiency and 8 trials welcoming participants who use Jatenzo medication."
What kind of qualifications must participants meet to be eligible for this research?
"This research is enrolling 40 volunteers aged 18 to 65 that display testosterone deficiency. In order for one's application to be valid, they must provide written consent prior to any procedures and comply with the regulations passed by an Institutional Review Board (IRB). Additionally, only males are eligible for this study."
Is the age range for this clinical trial limited to those over 25 years old?
"The age requirements for this trial are clearly outlined in the enrollment criteria: patients must be of legal consent and not exceed 65 years old."
What is the aim of this experiment?
"The primary endpoint of this research, that will be assessed between Baseline and 3 months as well as Baseline and 6 months, is the transformation in patient satisfaction determined by TSQM-9. Secondary endpoints include alteration in Estrogen levels (pg/mL) measured via venous puncture blood draw; change in Prostate Specific Antigen (PSA) levels (ng/dL), also obtained through venipuncture; and transformations in Testosterone concentrations (ng/dL)."
Has the governmental body given Jatenzo its seal of approval?
"As it is a Phase 4 trial, Jatenzo has already been approved and thus was given an appropriate safety score of 3."
Can you elaborate on any prior research regarding Jatenzo?
"Currently, 8 clinical trials are underway for Jatenzo. As of now, none have progressed to Phase 3 yet. Although the primary testing site is located in Boston, Massachusetts, 46 different locations are running studies related to this medication."
What is the size of the sample population currently participating in this trial?
"Currently, this clinical trial is not recruiting participants. This study was first listed on June 18th 2021 and the last update occurred November 7th 2022. For those exploring other medical studies, there are 6 trials looking to recruit people with testosterone deficiency and 8 trials actively enrolling for Jatenzo therapy."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
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Most responsive sites:
- University of Miami: < 24 hours
Average response time
- < 2 Days
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