Testosterone Undecanoate and Quality of Life of Men and Spouses

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01758029
• Other study ID #: NBD01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2012
• Last updated: December 23, 2012
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2012
• Source: Meir Medical Center
• Contact: uri gur, MD
• Phone: 972-54-7738384
• Email: urigurmd[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• testosterone undecanoate
treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient and spouse satisfaction an quality of life	the outcome measure will be assessed with various validated questionnaires.	28 weeks	No