Daily Tadalafil on Body Fat and Lean Mass

NCT02554045 | Completed Phase 4 DMC

• 1 other identifier: FDAAA 801
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Data confirming a role for PDE5 in adipocyte biology in vitro have been recently reported. However, a better understanding of the complex role of PDE5 in fat metabolism and whole body homeostasis requires the use of transgenic animal models either lacking or overexpressing PDE5 in adipose tissue. This will clarify the role of PDE5 in adipose expansion and metabolism, and also in glucose homeostasis and vascular function in vivo. Analysis of expression and activity of PDE5 in different sites of human adipose tissue (i.e. visceral vs. subcutaneous), and also in different metabolic conditions (i.e. high-fat diet vs. low calorie intake) could reveal if PDE5 can be considered to be a reliable 'marker' of metabolic dysfunction of the adipocyte. Importantly, chronic treatment with the PDE5 inhibitor sildenafil in a mouse model of diet-induced insulin resistance caused a significant improvement in insulin sensitivity . Also, in humans chronic exposure to tadalafil confirmed an improvement of insulin sensitivity in men with erectile dysfunction. However, the efficacy of long-term treatment with PDE5i awaits demonstration in human metabolic diseases such as obesity and insulin resistance. The primary purpose of the study is to investigate the effects of tadalafil taken once a day on body composition in men with sexual distress and/or erectile dysfunction.

Conditions

Obesity; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Variation in lean and fat mass (overall and as evaluated by whole body DEXA Hologic-QDR1000

  Changes from baseline in the percentage of lean (overall estimation) and fat mass (abdominal area) and vs. control group as evaluated by whole body dual-energy X-ray absorptiometry (DEXA-HOLOGIC QDR-1000).

  8 weeks

Secondary Outcomes (3)

• Sexual domains (IIEF-5 scores)

  8 weeks

• Body Mass Index (BMI)

  8 weeks

• Hormonal variations from baseline and vs control group (Testosterone estradiol levels)

  8 weeks

Study Arms (2)

Tadalafil

ACTIVE COMPARATOR

Patients will take tadalafil 2.5 mg tablet every morning for 8 weeks and then withdraw tadalafil for 8 weeks

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

Patients will take placebo tablet every morning for 8 weeks and then withdraw placebo for 8 weeks

Drug: Placebo

Interventions

Tadalafil DRUG

Patients will take tadalafil 2.5 mg tablet every morning for 8 weeks and then withdraw tadalafil for 8 weeks

Also known as: Cialis

Tadalafil

Placebo DRUG

Patients will take placebo tablet every morning for 8 weeks and then withdraw placebo for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects greater than 18 years with any BMI who volunteered to enter the study because of the presence of sexual distress and/or mild erectile dysfunction.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (3)

• Aversa A, Fittipaldi S, Bimonte VM, Wannenes F, Papa V, Francomano D, Greco EA, Lenzi A, Migliaccio S. Tadalafil modulates aromatase activity and androgen receptor expression in a human osteoblastic cell in vitro model. J Endocrinol Invest. 2016 Feb;39(2):199-205. doi: 10.1007/s40618-015-0344-1. Epub 2015 Jul 2.

  PMID: 26134065 RESULT

• Porst H, Brock GB, Kula K, Moncada I, Montorsi F, Basson BR, Kinchen K, Aversa A. Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors. J Androl. 2012 Nov-Dec;33(6):1305-22. doi: 10.2164/jandrol.111.015289. Epub 2012 Jul 12.

  PMID: 22790642 RESULT

• Aversa A, Caprio M, Antelmi A, Armani A, Brama M, Greco EA, Francomano D, Calanchini M, Spera G, Di Luigi L, Rosano GM, Lenzi A, Migliaccio S, Fabbri A. Exposure to phosphodiesterase type 5 inhibitors stimulates aromatase expression in human adipocytes in vitro. J Sex Med. 2011 Mar;8(3):696-704. doi: 10.1111/j.1743-6109.2010.02152.x. Epub 2010 Dec 22.

  PMID: 21176111 RESULT

MeSH Terms

Conditions

Obesity; Sexual Dysfunction, Physiological

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Antonio Aversa, MD-PHD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 18, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share