Co-Administering Testosterone With PDE5 Inhibitors in ED Patients Non Responders to PDE5 Inhibitors Alone

Summary

30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V Inhibitor therapy, which is presently considered as the first choice treatment for most ED patients. Recent reports stated a high prevalence of low serum testosterone levels in such non responders, and an improvement of their response by combining testosterone therapy with the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo controlled studies have added support to this hypothesis but one involved only 20 patients while in the other the benefit of combining testosterone was transient. This is a multi-centric study, double blind placebo controlled and randomized as concerns testosterone administration, that aims to objectively assess the efficacy of co-administering testosterone with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure inclusion and exclusion criteria completion, including a serum testosterone level \< 4 ng/ml for total testosterone or \< 1 ng/ ml for bioavailable testosterone. They will then enter a four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily, in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question (GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a 12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study visit. Safety assessments will be performed in addition during the last visit (physical examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel + Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated according to suboptimal clinical response of the patient, the dose of study medication will be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind treatment phase.

Conditions

• Erectile Dysfunction
• Hypogonadism

Interventions

DRUG

Testosterone gel

one sachet of 50 mg applied once a day, possibly titrated to two sachets if insufficient improvement of erectile function

DRUG

testosterone

testosterone gel, one sachet of 50 mg applied once a day, possibly titrated to 100 mg if insufficient effect

OTHER

placebo gel

one sachet of placebo gel once a day possibly titrated to 2 sachets if insufficient efficacy

Sponsors & Collaborators

• Bayer

  collaborator INDUSTRY

• SELARL du Dr Jacques BUVAT

  lead OTHER

Principal Investigators

• Jacques BUVAT, MD · SELARL du Dr Jacques BUVAT

• Eugene PLAS, MD · Lainz Hospital Vienna - Austria

• Claude SCHULMAN, MD · Erasme Hospital Brussels

• Francois GIULIANO, MD · Hopital Raymond Poincaré - Garches - France

• Béatrice CUZIN, MD · CHU Edouard Herriot - Lyon - France

• Marie Hélène COLSON, MD · Centre du Palais - Marseille - France

• Hartmut PORST, MD · Urological Office - Hamburg - Germany

• Christian STIEF, MD · Ludwig Maximilians Universität - Munchen - Germany

• Aksam YASSIN, MD · Urological Office - Hamburg - Germany

• Theodor KLOTZ, MD · Klinikum fur Urologie - Weiden - Germany

• Francesco MONTORSI, MD · Hospital San Raffaele - Milano - Italy

• Mario MAGGI, MD · Andrology Unit - Florence - Italy

• Anti KAIPIA, MD · Gynecologi - Ja Urologikeskus - Tampere - Finland

• Eric MEULEMAN, MD · Free University Medical Center - Amsterdam - The Netherlands

• Antonio MARTIN MORALES, MD · Hospital Carlos Haya - Malaga - SPAIN

• Ignacio MONCADA, MD · Hospital Gregorio Maranon - Madrid - SPAIN

• John DEAN, MD · Salisbury Clinic - Plymouth - UK

• Ian EARDLEY, MD · Leeds Hospital - Leeds - UK

• Jacques BUVAT, MD · CETPARP - Lille - France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-10-31

Primary Completion

2007-07-31

Completion

2007-07-31

Countries

• France

Study Locations