A Study in Erectile Dysfunction
3. desember 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
623
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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.
-
-
-
-
Alabama
-
Huntsville, Alabama, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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, Forente 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.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
i 12 uker
|
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
|
Administer orally
Andre navn:
|
|
Aktiv komparator: 5 mg Tadalafil
5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks
|
Administer orally
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kim E, Seftel A, Goldfischer E, Baygani S, Burns P. Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. Curr Med Res Opin. 2015 Feb;31(2):379-89. doi: 10.1185/03007995.2014.989317. Epub 2014 Dec 2.
- Kim ED, Seftel AD, Goldfischer ER, Ni X, Burns PR. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. J Sex Med. 2014 Mar;11(3):820-30. doi: 10.1111/jsm.12253. Epub 2013 Jul 10.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2010
Primær fullføring (Faktiske)
1. januar 2012
Studiet fullført (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først innsendt
24. mai 2010
Først innsendt som oppfylte QC-kriteriene
24. mai 2010
Først lagt ut (Anslag)
26. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. januar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. desember 2012
Sist bekreftet
1. desember 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13461 (UKCRN)
- H6D-US-LVIP (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .