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testosterone 1.62% gel for Testicular Hypogonadism

Georgia Cancer Center at Augusta University, Augusta, GA
Targeting 3 different conditionstestosterone 1.62% gel +1 morePhase 2RecruitingResearch Sponsored by Seattle Institute for Biomedical and Clinical Research

Study Summary

This trial is testing whether testosterone replacement can help with cancer-related fatigue in older men who have low testosterone levels.

Eligible Conditions
  • Testicular Hypogonadism
  • Cancer
  • Fatigue

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 6 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue change
Secondary outcome measures
Change in Sexual Activity Score
Other outcome measures
Body Composition Changes
Caregiver Burden Changes
Change in Mood and Well-being
+7 more

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: testosterone 1.62% gelExperimental Treatment1 Intervention
Testosterone 1.62% gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.
Group II: placebo gelPlacebo Group1 Intervention
The placebo gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.

Find a site

Who is running the clinical trial?

Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
52 Previous Clinical Trials
13,170 Total Patients Enrolled
1 Trials studying Testicular Hypogonadism
240 Patients Enrolled for Testicular Hypogonadism

Media Library

Placebo Gel Clinical Trial Eligibility Overview. Trial Name: NCT04301765 — Phase 2
Testicular Hypogonadism Research Study Groups: placebo gel, testosterone 1.62% gel
Testicular Hypogonadism Clinical Trial 2023: Placebo Gel Highlights & Side Effects. Trial Name: NCT04301765 — Phase 2
Placebo Gel 2023 Treatment Timeline for Medical Study. Trial Name: NCT04301765 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to enroll patients in this clinical trial?

"According to the website clinicaltrials.gov, this particular trial is still looking for participants and is currently in the recruitment stage. This trial was first posted on 1/12/2021 and was last edited on 3/9/2022."

Answered by AI

Has research been published on 1.62% testosterone gel in the past?

"At this time, there are a total of 32 active studies on testosterone 1.62% gel with 5 being in Phase 3. Most investigations for testosterone 1.62% gel take place in Houston, Texas; however, there are 158 locations worldwide conducting clinical trials for this medication."

Answered by AI

Could you please list the potential side effects of using testosterone 1.62% gel?

"Although there is some evidence indicating that testosterone 1.62% gel is safe, it only received a score of 2 because this is a Phase 2 trial with no data supporting efficacy."

Answered by AI

What is the general purpose of testosterone 1.62% gel?

"Patients suffering from hypogonadotropic hypogonadism, post-menopausal women 1 to 5 years after menopause, and those that have had an orchidectomy can all be treated with testosterone 1.62% gel."

Answered by AI

How many participants are being welcomed into this research?

"That is correct. According to the listings on clinicaltrials.gov, this study is still looking for participants. The posting date was 1/12/2021 with a most recent update on 3/9/2022. They are aiming to enroll 230 total patients from 3 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Jose Manuel Garcia 2021. "Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04301765.
~105 spots leftby Jan 2026
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