Testosterone Undecanoate and Quality of Life of Men and Spouses

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will be conducted as a prospective, single-center (multiple clinics), single-arm open phase IV study.

the study will follow hypogonadal patients, and aimed to confirm the hypothesis that testosterone undecanoate improves the patient satisfaction and quality of life, with parallel improvement in their spouses's quality of life and satisfaction. Each patient/spouse will serve as his own control.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meir Medical Center
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Hypogonadal patient age 40 to 80 who has newly been prescribed testosterone undecanoate.

• The patient must be in a stable (>3 months) heterosexual relationship to be eligible for the study

• Diagnosis of hypogonadism at the discretion of the physician, based on patient's symptoms and a laboratory evidence of T levels below 12 (symptomatic patients with borderline levels of 8.4 to 12 are also eligible for testosterone replacement therapy)

• Wash-out of 6 months for testosterone undecanoate, 4 weeks for other testosterone formulations, before study entry.

• Patient & spouse must be capable and willing to fill-in questionnaires to be enrolled in the study

• Informed consent is required

Exclusion Criteria:

• The standard contraindications and warnings of treatment with testosterone replacement therapy, and specifically testosterone undecanoate, must be followed. Contra-indications as copied from the product prescribing information are: androgen-dependent carcinoma of the prostate or of the male mammary gland; past or present liver tumors; hypersensitivity to the active substance or to any of the excipients

• Men with desired paternity will be excluded