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Clinical Trials/EUCTR2007-007670-38-FR
EUCTR2007-007670-38-FR
Active, not recruiting
Not Applicable

Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by Testopatch

Pierre Fabre Médicament0 sites104 target enrollmentMay 5, 2008
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ConditionsTestosterone deficiencyErectile dysfunctionMedDRA version: 9.1Level: LLTClassification code 10061461Term: Erectile dysfunctionMedDRA version: 9.1Level: LLTClassification code 10058359Term: Hypogonadism
DrugsTestopatchCIALIS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Testosterone deficiencyErectile dysfunction
Sponsor
Pierre Fabre Médicament
Enrollment
104
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 5, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Pierre Fabre Médicament

Eligibility Criteria

Inclusion Criteria

  • •?Men over 18 years old,
  • •?With a history of ED (defined as the inability to achieve or maintain an erection sufficient to permit satisfying sexual performance) for at least three months,
  • •?Erectile function (EF) domain score of the International Index of Erectile Function (IIEF) \< 21,
  • •?Body\-mass index (BMI) ? 32 kg/m2,
  • •?Serum total testosterone (TT) \< 3\.46 ng/mL (12 nmol/L ) or bioavailable testosterone (BT) \< 0\.8 ng/mL (2\.3 nmol/L) confirmed on 2 blood samples collected on 2 different days between 7 \- 11a.m.,
  • •?Never treated for testosterone deficiency or have not received testosterone treatment within the last year,
  • •?Never treated for ED with a PDE5 inhibitor or not treated for at least 3 months,
  • •?Who agree to have at least two sexual intercourse attempts during the selection period, and an average of one sexual intercourse attempt weekly during the study period,
  • •?Who agree not to use any other treatment for ED during the study period (including vacuum and herbal therapies),
  • •?Having signed their written informed consent,

Exclusion Criteria

  • •Criteria related to pathologies
  • •?Penile prosthesis, significant congenital or acquired penile deformation, or any organic aetiology,
  • •?Hyperprolactinemia defined as serum prolactin \>50 ng/mL,
  • •?Severe depression ,
  • •?Benign prostate hyperplasia with severe lower urinary tract symptoms as defined by an International Prostate Symptom Score (IPSS) \>19,
  • •?History of prostate or breast cancer,
  • •?Known acute or chronic prostate pathology, and/or PSA \> 2 ng/mL, and/or suspicion of prostate cancer,
  • •?Presence or history of liver tumour,
  • •?Severe hepatic, renal or respiratory failure,
  • •?Congestive heart failure (NYHA class II, III or IV),

Outcomes

Primary Outcomes

Not specified

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