NCT01123278

Brief Summary

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2004

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

10.8 years

First QC Date

May 10, 2010

Last Update Submit

October 25, 2014

Conditions

HypogonadismMetabolic SyndromeObesityErectile Dysfunction

Keywords

AdiponectinResistinAdipocytesTestosteroneAgingHOMA-IRInsulinHypogonadismMetabolic SyndromeObesityErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Fat-Free Mass (kg)

    Estimate of within subject absolute change in fat-free mass measured by DEXA (dual energy x-ray absorptiometry) at 3 months (90 days) interval during active or placebo treatment.

    3 months

Secondary Outcomes (16)

  • Fat Mass (kg)

    3 months

  • HOMA-IR (homeostasis model assessment)- (insulin resistance)

    3 months

  • CRP (C reactive protein)

    3 months

  • Interleukins

    3 months

  • Adipokines

    3 months

  • +11 more secondary outcomes

Study Arms (2)

Testosterone gel

EXPERIMENTAL

Testosterone transdermal gel 50 mg/day

Drug: Testosterone

Placebo gel

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo

Interventions

TestosteroneDRUG

Testosterone transdermal gel 50 mg/day (5 gr)

Also known as: Androgel, Testogel
Testosterone gel
PlaceboDRUG

Placebo transdermal gel (5 gr)

Placebo gel

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Metabolic Syndrome according to ATPIII
  • patients with mild hypogonadism (both testosterone evaluations between 6 and 11 nmol/L)
  • patients naïve to hypoglycemic therapies

You may not qualify if:

  • patients on hypoglycemic medications
  • patients with severe hypogonadism (\<5 nmol/L)
  • patients with borderline T values hypogonadism (\>11 nmol/L)
  • patients with contraindication to testosterone therapy: prostate cancer, PSA\>4 ng/ml, severe hepatic or renal insufficiency, Hb\>17, Htc\>52%, severe urinary retention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Policlinico Umberto I Hospital - Sapienza University

Rome, Rome, 00161, Italy

Location

Dipartimento di Fisiopatologia Medica - Policlinico Umberto I

Rome, 00161, Italy

Location

Related Publications (9)

  • Isidori AM, Caprio M, Strollo F, Moretti C, Frajese G, Isidori A, Fabbri A. Leptin and androgens in male obesity: evidence for leptin contribution to reduced androgen levels. J Clin Endocrinol Metab. 1999 Oct;84(10):3673-80. doi: 10.1210/jcem.84.10.6082.

    PMID: 10523013BACKGROUND

  • Aversa A, Isidori AM, Greco EA, Giannetta E, Gianfrilli D, Spera E, Fabbri A. Hormonal supplementation and erectile dysfunction. Eur Urol. 2004 May;45(5):535-8. doi: 10.1016/j.eururo.2004.01.005.

    PMID: 15082192BACKGROUND

  • Isidori AM, Giannetta E, Pozza C, Bonifacio V, Isidori A. Androgens, cardiovascular disease and osteoporosis. J Endocrinol Invest. 2005;28(10 Suppl):73-9.

    PMID: 16550728BACKGROUND

  • Isidori AM, Greco EA, Aversa A. Androgen deficiency and hormone-replacement therapy. BJU Int. 2005 Aug;96(2):212-6. doi: 10.1111/j.1464-410X.2005.05603.x. No abstract available.

    PMID: 16001962BACKGROUND

  • Isidori AM, Giannetta E, Greco EA, Gianfrilli D, Bonifacio V, Isidori A, Lenzi A, Fabbri A. Effects of testosterone on body composition, bone metabolism and serum lipid profile in middle-aged men: a meta-analysis. Clin Endocrinol (Oxf). 2005 Sep;63(3):280-93. doi: 10.1111/j.1365-2265.2005.02339.x.

    PMID: 16117815BACKGROUND

  • Isidori AM, Giannetta E, Gianfrilli D, Greco EA, Bonifacio V, Aversa A, Isidori A, Fabbri A, Lenzi A. Effects of testosterone on sexual function in men: results of a meta-analysis. Clin Endocrinol (Oxf). 2005 Oct;63(4):381-94. doi: 10.1111/j.1365-2265.2005.02350.x.

    PMID: 16181230BACKGROUND

  • Isidori AM, Lenzi A. Testosterone replacement therapy: what we know is not yet enough. Mayo Clin Proc. 2007 Jan;82(1):11-3. doi: 10.4065/82.1.11. No abstract available.

    PMID: 17285780BACKGROUND

  • Aversa A, Isidori AM, Spera G, Lenzi A, Fabbri A. Androgens improve cavernous vasodilation and response to sildenafil in patients with erectile dysfunction. Clin Endocrinol (Oxf). 2003 May;58(5):632-8. doi: 10.1046/j.1365-2265.2003.01764.x.

    PMID: 12699447BACKGROUND

  • Aversa A, Isidori AM, De Martino MU, Caprio M, Fabbrini E, Rocchietti-March M, Frajese G, Fabbri A. Androgens and penile erection: evidence for a direct relationship between free testosterone and cavernous vasodilation in men with erectile dysfunction. Clin Endocrinol (Oxf). 2000 Oct;53(4):517-22. doi: 10.1046/j.1365-2265.2000.01118.x.

    PMID: 11012578BACKGROUND

MeSH Terms

Conditions

HypogonadismMetabolic SyndromeObesityErectile DysfunctionInsulin Resistance

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Vincenzo Bonifacio, MD, PhD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

  • Andrea M Isidori, MD, PhD

    University of Roma La Sapienza

    STUDY DIRECTOR

  • Andrea Lenzi, MD, PhD

    University of Roma La Sapienza

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 14, 2010

Study Start

January 1, 2004

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

IT(2)