Hypogonadism Clinical Trial
Official title:
Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate
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.
the study protocol will follow hypogonadal patients, who initiate treatment with
testosterone undecanoate, given in accordance with the standard protocol.
Hypogonadal men eligible for treatment with testosterone undecanoate, who have not been
treated with testosterone undecanoate within the last 6 months prior to enrollment, can be
enrolled in the study. Patients who were treated with another testosterone formulation (eg.
testosterone gel, testosterone enanthate injections) will require a 4 week wash-out period.
Patients must be enrolled after the decision for treatment with testosterone undecanoate has
been made.
Patients will be followed for an observation period of 28 weeks. Observations will be
recorded at 3 consecutive visits, and will assess patient and spouse satisfaction and
quality of life with validated questionnaires.
The study design is an intra-individual comparison. Each patient/spouse serves as his own
control.
a laboratory test for total testosterone level will be required in the last visit. the need
for concomitant phosphodiesterase-5 inhibitors use will also be recorded and analyzed.
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Observational Model: Cohort, Time Perspective: Prospective
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