Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Launched by TULANE UNIVERSITY · Oct 19, 2020

Keywords

ClinConnect Summary

This clinical trial is looking to see how testosterone treatment affects various health issues in men with multiple sclerosis (MS) who have low testosterone levels. Specifically, the researchers want to find out if this treatment can improve erectile function, reduce fatigue and depression, enhance cognitive abilities, and improve overall quality of life. The study will include men aged 18 and older who have been diagnosed with MS and have low testosterone levels. Participants will need to be sexually active and willing to complete several questionnaires and undergo some medical tests, including blood draws and exams.

To join the study, men should not be currently experiencing an MS relapse and must not have taken certain hormone treatments or medications in the past year. There are also specific health conditions that would disqualify someone from participating, like serious heart or kidney issues, or a history of certain cancers. If eligible, participants can expect to attend regular visits to the research site and provide feedback on their health through questionnaires. This study is not yet recruiting participants, so there's still time to learn more before deciding to take part.

Gender

MALE

Eligibility criteria

• 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.
• • Patients with BMI ≥ 35
• • Patients with generalized skin disease that may affect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.
• • Patients with history of pituitary disease.
• • Patients with a cholesterol level greater than 300 mg/dl.
• • Patients who are receiving or have received experimental therapies in the six months preceding enrollment.
• • Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).
• • Patients who have clinical evidence of Lyme disease.
• • Males who are trying to get their partner pregnant.
• • Patients on Finasteride
• • Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.
• • Any other contraindications according to the manufacturer's exclusion criteria.