Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study in Erectile Dysfunction

3. december 2012 opdateret af: Eli Lilly and Company

Tadalafil Once Daily Following As-Needed Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function

The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Erektil dysfunktion

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

623

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- British Columbia
  - Langley, British Columbia, Canada, V3A 4H9
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Victoria, British Columbia, Canada, V8T 5G1
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - North York, Ontario, Canada, M3B 3S6
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Quebec
  - Montreal, Quebec, Canada, H2X 1N8
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7K 7H9
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Forenede Stater
- Alabama
  - Huntsville, Alabama, Forenede Stater, 35801
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- California
  - Lancaster, California, Forenede Stater, 93534
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Newport Beach, California, Forenede Stater, 92660
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - San Diego, California, Forenede Stater, 92103
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Spring Valley, California, Forenede Stater, 91978
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Tarzana, California, Forenede Stater, 91356
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Connecticut
  - New Britain, Connecticut, Forenede Stater, 06052
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Florida
  - Aventura, Florida, Forenede Stater, 33180
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Fort Lauderdale, Florida, Forenede Stater, 33316
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Oviedo, Florida, Forenede Stater, 32765
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Idaho
  - Meridian, Idaho, Forenede Stater, 83646
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Nampa, Idaho, Forenede Stater, 83686
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Kansas
  - Lansing, Kansas, Forenede Stater, 66043
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Topeka, Kansas, Forenede Stater, 66606
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Massachusetts
  - Haverhill, Massachusetts, Forenede Stater, 01830
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Michigan
  - Troy, Michigan, Forenede Stater, 48085
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- New Jersey
  - Toms River, New Jersey, Forenede Stater, 08753
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- New York
  - Garden City, New York, Forenede Stater, 11530
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Poughkeepsie, New York, Forenede Stater, 12601
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- North Carolina
  - Concord, North Carolina, Forenede Stater, 28025
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Wilmington, North Carolina, Forenede Stater, 28401
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58103
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Ohio
  - Lyndhurst, Ohio, Forenede Stater, 44124
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Pennsylvania
  - Bala Cynwyd, Pennsylvania, Forenede Stater, 19004
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Greer, South Carolina, Forenede Stater, 29651
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Mt. Pleasant, South Carolina, Forenede Stater, 29464
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Tennessee
  - Knoxville, Tennessee, Forenede Stater, 37920
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Texas
  - Austin, Texas, Forenede Stater, 78731
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - San Antonio, Texas, Forenede Stater, 78258
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Utah
  - Clinton, Utah, Forenede Stater, 84015
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Washington
  - Bellevue, Washington, Forenede Stater, 98007
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Seattle, Washington, Forenede Stater, 98166
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Spokane, Washington, Forenede Stater, 99220
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

At least a 3-month history of erectile dysfunction (ED).
Are able to read, understand and provide signed informed consent.
Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.

Partner Inclusion Criteria:

Are female and at least 18 years of age at screening.
Anticipate having the same male study subject as her sexual partner during the study.
Able to read, understand and provide signed informed consent.
Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
Willing to participate in recording responses to the treatment satisfaction scale.

Exclusion Criteria:

Have an IIEF-EF domain score of greater than or equal to 26 at screening.
Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
Have previously used or are currently using any PDE5 inhibitor once daily.
Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
Partner unwilling to complete all study requirements.
History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Tredobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Placebo komparator: Placebo i 12 uger	Medicin: Placebo Administer orally
Aktiv komparator: 2.5 milligram (mg) titrated to 5 mg Tadalafil 2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks	Medicin: Tadalafil Administer orally Andre navne: LY450190 Cialis
Aktiv komparator: 5 mg Tadalafil 5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks	Medicin: Tadalafil Administer orally Andre navne: LY450190 Cialis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) Tidsramme: Baseline through 12 weeks	Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).	Baseline through 12 weeks

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Tidsramme: Baseline, 12 weeks	Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score Tidsramme: Baseline, 12 weeks	Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score Tidsramme: Baseline, 12 weeks	Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5 Tidsramme: Baseline, 12 weeks	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient Tidsramme: Baseline, 12 weeks	The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint Tidsramme: Week 12	The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.	Week 12
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence) Tidsramme: Baseline, 12 weeks	Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner Tidsramme: Baseline, 12 weeks	The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.	Baseline, 12 weeks
Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint Tidsramme: Week 12	The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.	Week 12
Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks Tidsramme: 12 weeks through 16 weeks	Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).	12 weeks through 16 weeks
Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Tidsramme: 12 weeks and 16 weeks	Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.	12 weeks and 16 weeks
Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3 Tidsramme: 12 weeks and 16 weeks	Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).	12 weeks and 16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2010

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

24. maj 2010

Først indsendt, der opfyldte QC-kriterier

24. maj 2010

Først opslået (Skøn)

26. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2012

Sidst verificeret

1. december 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

13461 (UKCRN)
H6D-US-LVIP (Anden identifikator: Eli Lilly and Company)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Erektil dysfunktion

Consorcio Centro de Investigación Biomédica en...
Hospital General Universitario Gregorio Marañon; Universidad Complutense... og andre samarbejdspartnere

Ikke rekrutterer endnu

Træning for en aldrende lever (EXALIVER) (EXALIVER)

Leverfibrose/NASH | MASH - Metabolic Dysfunction-Associated Steatohepatitis | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Spanien
Rivus Pharmaceuticals, Inc.

Rekruttering

Et forsøg til at undersøge sikkerhed, eksponering og effekt af HU6 sammenlignet med placebo hos voksne deltagere med metabolisk dysfunktions-associeret steatohepatitis (MASH) (AMPLIFY)

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Forenede Stater
Madrigal Pharmaceuticals, Inc.

Rekruttering

Rezdiffra Graviditets- og Ammeplejeregister

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Forenede Stater
Shanghai East Hospital

Rekruttering

Højrisiko-transkriptom molekylær forudsigelsesundersøgelse af MASH-associerede kolorektale polypper

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Kina
Southern California Institute for Research and...

Ikke rekrutterer endnu

En fase II RCT-undersøgelse af betain versus placebo for serologisk diagnosticeret metabolisk dysfunktions-associeret steatohepatitis (MASH)

MASH - Metabolic Dysfunction-Associated Steatohepatitis
Nabiqasim Industries (Pvt) Ltd

Rekruttering

Resmiterom Effektivitet & Sikkerhed hos Patienter med MASH (REZMASH)

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Pakistan
Stimdia Medical, Inc.

Afsluttet

PEPNS System Feasibility Undersøgelse

Ventilator-induceret diaphragmatic dysfunction (VIDD)

Irland, Tjekkiet
Fondazione Policlinico Universitario Agostino Gemelli...

Rekruttering

Måling af miltstivhed til detektering af avanceret fibrose (S-MASH)

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Italien
Tangram Therapeutics Plc

Rekruttering

Undersøgelse af TGM-312-SC01 hos raske deltagere og voksne med MASH

Sunde deltagere | MASH - Metabolic Dysfunction-Associated Steatohepatitis

Det Forenede Kongerige
University of Campania Luigi Vanvitelli

Afsluttet

Effekter af langvarig bicarbonat-sulfat-calcium-magnesiumvandsindtag på metabolisk dysfunktion-associeret steatotisk leversygdom (MASLD) -relateret resultat (FonteESSEMASLD)

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Italien

Kliniske forsøg med Tadalafil

Centro Universitario de Ciencias de la Salud, Mexico

Ukendt

Effekt af tadalafil administration på vasodilatation medieret af flow hos patienter med fedme grad I-II

Fedme og erektil dysfunktion

Mexico
Futura Medical Developments Ltd.

Afsluttet

Klinisk undersøgelse ved brug af MED3000 gel eller tadalafil tabletter til behandling af erektil dysfunktion

Erektil dysfunktion

Forenede Stater, Bulgarien, Georgien, Polen
Institute for the Study of Urological Diseases,...

Rekruttering

Lav-intensitet stødbølgeterapi + Tadalafil 5mg til behandling af svær erektil dysfunktion

Erektil dysfunktion

Grækenland
Saint Petersburg State University, Russia

Rekruttering

Effekt og sikkerhed af fokuseret stødbølgeterapi plus tadalafil vs tadalafil alene hos patient med erektil dysfunktion

Erektil dysfunktion

Den Russiske Føderation
Cairo University

Ukendt

Kombineret effekt af kontinuerlig og interval ud over tadalafil lægemiddel på erektil dysfunktion

Erektil dysfunktion

Egypten
Cedars-Sinai Medical Center

Afsluttet

PDE-hæmmere i DMD-undersøgelse (akut doseringsundersøgelse)

Duchennes muskeldystrofi

Forenede Stater
Erasmus Medical Center

Afsluttet

En undersøgelse for at vurdere effektiviteten af tadalafil til behandling af erektil dysfunktion efter strålebehandling af prostatakræft

Erektil dysfunktion | Prostatakræft

Holland
University of Arkansas

Trukket tilbage

Brug af en fosfodiesterase type 5-hæmmer til at forbedre anabolsk modstand hos ældre voksne

Sarkopeni

Forenede Stater
Aswan University

Afsluttet

Serum YKL-40 niveau og blodpladeindekser blandt patienter med diabetisk erektil dysfunktion

Erektil dysfunktion | Erektil dysfunktion med diabetes mellitus

Egypten
Santa Barbara Cottage Hospital

Trukket tilbage

Brugen af Tadalafil ved bekræftet COVID-19-lungebetændelse.

COVID | ARDS, menneske | SARS-CoV-2

A Study in Erectile Dysfunction

Tadalafil Once Daily Following As-Needed Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Erektil dysfunktion

Kliniske forsøg med Tadalafil

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer