HypogonadismNCT01758029
Testosterone Undecanoate and Quality of Life of Men and Spouses
An observational study of Hypogonadism, run by Meir Medical Center.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- testosterone undecanoate
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: community based population of hypogonadal men, who are eligible and choose the treatment with testosterone undecanoate
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hypogonadism
- Being tested
- testosterone undecanoate
- Keywords
- quality of life, Testosterone Undecanoate, partner, questionnaire
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone undecanoateDrug
Also called Nebido 1000mg
treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Undecanoate | treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18. Receives: Drug: testosterone undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient and spouse satisfaction an quality of life
the outcome measure will be assessed with various validated questionnaires.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- uri gur, MD, Principal investigator, Israel: Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758029
- Sponsor's protocol ID
- NBD01
- Status last verified
- Dec 2012
- First submitted
- 23 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
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. No abstract available.
PubMed 18955511Saad 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.
PubMed 21753068Giltay 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.
PubMed 20524974Zitzmann 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.
PubMed 22812645Riley 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.
PubMed 11850743Rosen 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.
PubMed 17378845Bettocchi 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.
PubMed 19758282Hassan 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.
PubMed 18179457Rosen 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.
PubMed 9187685Heinemann LA. Aging Males' Symptoms scale: a standardized instrument for the practice. J Endocrinol Invest. 2005;28(11 Suppl Proceedings):34-8.
PubMed 16760622Rosen 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.
PubMed 17627746
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate
- ClinicalTrials.gov ID
- NCT01758029
- Acronym / sponsor ID
- NBD01
- Conditions
- Hypogonadism
- Keywords
- quality of life, Testosterone Undecanoate, partner, questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone Undecanoate | – | Drug: testosterone undecanoatetreatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community based population of hypogonadal men, who are eligible and choose the treatment with testosterone undecanoate
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone undecanoateAlso: Nebido 1000mgtreatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18. | Drug | Testosterone Undecanoate |
Primary outcome
patient and spouse satisfaction an quality of life
Time frame: 28 weeks
the outcome measure will be assessed with various validated questionnaires.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
- Background: PubMed 18955511Wang 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.
- Background: PubMed 21753068Saad 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.
- Background: PubMed 20524974Giltay 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.
- Background: PubMed 22812645Zitzmann 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.
- Background: PubMed 11850743Riley 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.
- Background: PubMed 17378845Rosen 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.
- Background: PubMed 19758282Bettocchi 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.
- Background: PubMed 18179457Hassan 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.
- Background: PubMed 9187685Rosen 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.
- Background: PubMed 16760622Heinemann LA. Aging Males' Symptoms scale: a standardized instrument for the practice. J Endocrinol Invest. 2005;28(11 Suppl Proceedings):34-8.
- Background: PubMed 17627746Rosen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
uri gur, MD principal investigator
Israel: Clalit Health Services
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact uri gur, MD (972-54-7738384, urigurmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient and spouse satisfaction an quality of life (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758029, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2012.