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Testosterone Undecanoate and Quality of Life of Men and Spouses

Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: testosterone undecanoate (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Meir Medical Center

Official(s) and/or principal investigator(s):
uri gur, MD, Principal Investigator, Affiliation: Israel: Clalit Health Services

Overall contact:
uri gur, MD, Phone: 972-54-7738384, Email: urigurmd@gmail.com


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.

Clinical Details

Official title: Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: patient and spouse satisfaction an quality of life

Detailed description: 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.


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Male.


Inclusion Criteria:

- Hypogonadal patient age 40 to 80 who has newly been prescribed testosterone


- 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

Locations and Contacts

uri gur, MD, Phone: 972-54-7738384, Email: urigurmd@gmail.com

Additional Information

Related publications:

Wang C, Nieschlag E, Swerdloff R, Behre HM, Hellstrom WJ, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morales A, Morley JE, Schulman C, Thompson IM, Weidner W, Wu FC. Investigation, treatment and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA and ASA recommendations. Eur J Endocrinol. 2008 Nov;159(5):507-14. doi: 10.1530/EJE-08-0601.

Saad F, Aversa A, Isidori AM, Zafalon L, Zitzmann M, Gooren L. Onset of effects of testosterone treatment and time span until maximum effects are achieved. Eur J Endocrinol. 2011 Nov;165(5):675-85. doi: 10.1530/EJE-11-0221. Epub 2011 Jul 13. Review.

Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.

Zitzmann M, Mattern A, Hanisch J, Gooren L, Jones H, Maggi M. IPASS: a study on the tolerability and effectiveness of injectable testosterone undecanoate for the treatment of male hypogonadism in a worldwide sample of 1,438 men. J Sex Med. 2013 Feb;10(2):579-88. doi: 10.1111/j.1743-6109.2012.02853.x. Epub 2012 Jul 19.

Riley A. The role of the partner in erectile dysfunction and its treatment. Int J Impot Res. 2002 Feb;14 Suppl 1:S105-9. Review.

Rosen RC, Fisher WA, Beneke M, Homering M, Evers T. The COUPLES-project: a pooled analysis of patient and partner treatment satisfaction scale (TSS) outcomes following vardenafil treatment. BJU Int. 2007 Apr;99(4):849-59.

Bettocchi C, Palumbo F, Spilotros M, Lucarelli G, Palazzo S, Battaglia M, Selvaggi FP, Ditonno P. Patient and partner satisfaction after AMS inflatable penile prosthesis implant. J Sex Med. 2010 Jan;7(1 Pt 1):304-9. doi: 10.1111/j.1743-6109.2009.01499.x. Epub 2009 Sep 15.

Hassan A, El-Hadidy M, El-Deeck BS, Mostafa T. Couple satisfaction to different therapeutic modalities for organic erectile dysfunction. J Sex Med. 2008 Oct;5(10):2381-91. doi: 10.1111/j.1743-6109.2007.00697.x. Epub 2007 Dec 27.

Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30.

Heinemann LA. Aging Males' Symptoms scale: a standardized instrument for the practice. J Endocrinol Invest. 2005;28(11 Suppl Proceedings):34-8. Review.

Rosen R, Goldstein I, Huang XY, Bangerter K, Taylor T. The Treatment Satisfaction Scale (TSS) is a sensitive measure of treatment effectiveness for both patients and partners: results of a randomized controlled trial with vardenafil. J Sex Med. 2007 Jul;4(4 Pt 1):1009-21.

Starting date: January 2013
Last updated: December 23, 2012

Page last updated: August 23, 2015

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