Clinical trial NCT04601233: Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
Official title: Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Multiple Sclerosis
Erectile Dysfunction
Testosterone Deficiency
Keywords: Multiple Sclerosis
Erectile Dysfunction
Testosterone Deficiency
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
name: Antares Pharma Inc.
First posted: 2020-10-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single open label
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Androgen Deficiency in the Aging Male (ADAM score).
timeFrame: Change from baseline to 12 weeks
measure: Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Sexual Health in Men (SHIM score).
timeFrame: Change from baseline to 12 weeks
measure: Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Male Sexual Health Questionnaire short form (MSHQ-SF).
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Measure the change in self-reported fatigue from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Modified Fatigue Impact Scale (MFIS).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported depression from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Beck Depression Inventory (BDI).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in cognitive function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Symbol Digit Modalities Test (SDMT).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in cognitive function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported overall quality of life from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Multiple Sclerosis Quality of Life Scale (MSQOL-54).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported urinary incontinence from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the American Urological Association Symptom Score (AUASS).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported urinary incontinence after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using International Consultation on Incontinence Questionnaire short form (ICIQ-SF).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported urinary incontinence from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Urogenital Distress Inventory short form (UDI-6).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported urinary incontinence from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Incontinence Impact Questionnaire short form (IIQ-7).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in self-reported pain from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the McGill Pain Questionnaire (MPQ).
timeFrame: Change from baseline to 12 weeks
measure: Measure the change in Multiple Sclerosis lesions, indirectly from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the serum levels of neurofilament-light chains (NF-L).
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Health Multispecilaity Clinics
state: Louisiana
Study officials:
affiliation: Assistant Professor, Urology
name: Omar A Raheem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bove R, Musallam A, Healy BC, Raghavan K, Glanz BI, Bakshi R, Weiner H, De Jager PL, Miller KK, Chitnis T. Low testosterone is associated with disability in men with multiple sclerosis. Mult Scler. 2014 Oct;20(12):1584-92. doi: 10.1177/1352458514527864. Epub 2014 Apr 7.
citation: Tehranipour M, Moghimi A. Neuroprotective effects of testosterone on regenerating spinal cord motoneurons in rats. J Mot Behav. 2010 May-Jun;42(3):151-5. doi: 10.1080/00222891003697921.
citation: Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683.
citation: Young CA, Tennant A; TONiC Study Group. Sexual functioning in multiple sclerosis: Relationships with depression, fatigue and physical function. Mult Scler. 2017 Aug 1;23(9):1268-1275. doi: 10.1177/1352458516675749. Epub 2016 Nov 1.
citation: Cunningham GR, Stephens-Shields AJ, Rosen RC, Wang C, Bhasin S, Matsumoto AM, Parsons JK, Gill TM, Molitch ME, Farrar JT, Cella D, Barrett-Connor E, Cauley JA, Cifelli D, Crandall JP, Ensrud KE, Gallagher L, Zeldow B, Lewis CE, Pahor M, Swerdloff RS, Hou X, Anton S, Basaria S, Diem SJ, Tabatabaie V, Ellenberg SS, Snyder PJ. Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels. J Clin Endocrinol Metab. 2016 Aug;101(8):3096-104. doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29.
citation: Yassin AA, Saad F. Treatment of sexual dysfunction of hypogonadal patients with long-acting testosterone undecanoate (Nebido). World J Urol. 2006 Dec;24(6):639-44. doi: 10.1007/s00345-006-0120-0.