Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003999

Trial Description

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Title

Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves
getting and maintaining an erection in men with erectile dysfunction and if there are
improvements in the sexual quality of life of the man and his female study partner

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003999
  •   2012/06/21
  •   2007/01/16
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00422734  (ClinicalTrials.gov)
  •   9501  (Eli Lilly and Company)
  •   H6D-MC-LVGH 
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Health Condition or Problem studied

  •   Impotence
  •   N48.4 -  Impotence of organic origin
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Interventions/Observational Groups

  •   Drug: tadalafil
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15); time frame: Baseline and 12 weeks
- Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ); time frame: Baseline and 12 weeks
- Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).; time frame: Baseline and 12 weeks

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Secondary Outcome

- Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response; time frame: Baseline and 12 weeks
- Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response; time frame: Baseline and 12 weeks
- Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain; time frame: 12 weeks
- Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response; time frame: Baseline and 12 weeks
- Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response; time frame: Baseline and 12 weeks
- Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response; time frame: Baseline and 12 weeks
- Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response; time frame: 12 weeks
- Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response; time frame: 12 weeks
- Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response; time frame: Baseline and 12 weeks
- Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire; time frame: Baseline and 12 weeks
- Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales; time frame: Baseline and 12 weeks

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Countries of Recruitment

  •   United States
  •   Austria
  •   France
  •   Germany
  •   Mexico
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2006/11/30
  •   342
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Male

- History of erectile dysfunction (ED) for at least 3 months duration

- Anticipate having the same female partner willing to participate throughout the study

- At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts
during the early phase of the study

- Adequate partner sexual function as determined by a Female Sexual Function Index

- Willing to record responses to efficacy questionnaires, sexual quality of life
questionnaires and other instruments used in the study

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Exclusion Criteria

- May not participate in the study if you have taken tadalafil previously.

- History of cardiac conditions including angina requiring treatment with nitrates,
heart disease of coronary conditions including myocardial infarction, bypass surgery,
angioplasty or stent placement for specified time before starting the study.

- Have sexual partner not willing to complete the scales.

- Use of nitrates.

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Addresses

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    • Eli Lilly and Company
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    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) 
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    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2008/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.