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Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis | Clinical Trials | Clareo Health

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Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)

NCT04601233•Tulane University

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.

Detailed Description

Volunteers will be treated weekly with Xyosted 75 mg (given subcutaneously) for 3 months during which they will have 3 study visits, 6 weeks apart. The Baseline visit will include providing a blood sample, completing questionnaires, receiving training on the Xyosted auto-injector, and undergoing a rectal exam for participants 55 years and older. Visits 2 and 3 will also include collecting a blood sample and completing questionnaires. At Visit 3, the rectal exam for those age 55 years and older will be repeated.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Males, age 18 years and older, with a definite diagnosis of multiple sclerosis.
•Low testosterone (\<300 ng/dl) on two successive blood draws before 9:00 am
•Not in an intercurrent relapse.
•Sexually active.
•Have subjective complaints about erectile function and libido.
•Must be willing and able to get labs drawn, complete questionnaires (BDI, MFIS, MSNQ, SDMT, MSQOL, ADAM, AUASS, SHIM, MSHQ, ICIQ, UDI, IIQ, MPQ) and commit to site visits schedule.

Exclusion Criteria

•Males unable to fulfill the above criteria and all female patients.
•Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.
•Males who have taken dehydroepiandrosterone (DHEA) during the 3 months prior to study.
•Patients who are taking anticoagulants or have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), urologic disease especially prostatic hypertrophy/nodules and testicular mass, or insulin-dependent diabetes.
•Patients with an abnormal prostate as evidenced by known history of prostatic disease, symptoms suggestive of prostatic disease or elevated levels of prostatic specific antigen (PSA 4 ng/ml or higher) measured within the last 12 months.
•Patients with history or complaint of testicular mass.
•Patients with hematocrit greater than 50%
•Patients with major psychiatric illness
•Patients with active alcoholism.
•Patients with a history of drug abuse within the past five years.
+10 more criteria

Locations (1)

LSU Health Multispecilaity Clinics

New Orleans, Louisiana, United States

Key Dates

Start Date

June 1, 2026

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

August 29, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple SclerosisErectile DysfunctionTestosterone Deficiency

Interventions

XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector

DRUG

Contacts

Michael Soliman, MD

CONTACT

504-756-4603 msoli2@lsuhsc.edu

Jesus Lovera, MD

CONTACT

504-568-4080 jlover@lsuhsc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

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