NCT01758029

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 31, 2012

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

December 23, 2012

Last Update Submit

December 23, 2012

Conditions

Hypogonadism

Keywords

quality of lifeTestosterone Undecanoatepartnerquestionnaire

Outcome Measures

Primary Outcomes (1)

  • patient and spouse satisfaction an quality of life

    the outcome measure will be assessed with various validated questionnaires.

    28 weeks

Study Arms (1)

Testosterone Undecanoate

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

Drug: testosterone undecanoate

Interventions

testosterone undecanoateDRUG

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

Also known as: Nebido 1000mg
Testosterone Undecanoate

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community based population of hypogonadal men, who are eligible and choose the treatment with testosterone undecanoate

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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. No abstract available.

    PMID: 18955511BACKGROUND

  • 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.

    PMID: 21753068BACKGROUND

  • 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.

    PMID: 20524974BACKGROUND

  • 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.

    PMID: 22812645BACKGROUND

  • Riley A. The role of the partner in erectile dysfunction and its treatment. Int J Impot Res. 2002 Feb;14 Suppl 1:S105-9. doi: 10.1038/sj.ijir.3900800.

    PMID: 11850743BACKGROUND

  • 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. doi: 10.1111/j.1464-410X.2006.06737.x.

    PMID: 17378845BACKGROUND

  • 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.

    PMID: 19758282BACKGROUND

  • 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.

    PMID: 18179457BACKGROUND

  • 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. doi: 10.1016/s0090-4295(97)00238-0.

    PMID: 9187685BACKGROUND

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

    PMID: 16760622BACKGROUND

  • 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. doi: 10.1111/j.1743-6109.2007.00527.x.

    PMID: 17627746BACKGROUND

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • uri gur, MD

    Israel: Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

uri gur, MD

CONTACT

972-54-7738384urigurmd@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2012

First Posted

December 31, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 31, 2012

Record last verified: 2012-12