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Testosterone Undecanoate and Quality of Life of Men and Spouses

This study is not yet open for participant recruitment.
Verified December 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01758029
First received: December 23, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Hypogonadism
 Drug: testosterone undecanoate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • patient and spouse satisfaction an quality of life [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    the outcome measure will be assessed with various validated questionnaires.


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Testosterone Undecanoate
treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.
 Drug: testosterone undecanoate
treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.
Other Name: Nebido 1000mg

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community based population of hypogonadal men, who are eligible and choose the treatment with 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758029

Contacts
Contact: uri gur, MD 972-54-7738384 urigurmd@gmail.com

Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: uri gur, MD Israel: Clalit Health Services
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01758029     History of Changes
Other Study ID Numbers: NBD01
Study First Received: December 23, 2012
Last Updated: December 23, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
quality of life
Testosterone Undecanoate
partner
questionnaire

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 23, 2013