Trial · NCT01937871
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | Baseline, Week 12 | All randomized participants who had at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Uroflowmetry Measures at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline Uroflowmetry measurement. | Milliliters/seconds (mL/sec) | MEAN |
| SECONDARY | Change From Baseline in Postvoid Residual Volume (PVR) at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PVR measurement. | milliliters (mL) | MEAN |
| SECONDARY | Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline QoL measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12 | Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PGI-I measurement. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12 | Week 12 | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline CGI-I measurement. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IIEF Intercourse Satisfaction at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IIEF Orgasmic Function at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IIEF Sexual Desire at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IIEF Subscores at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total IPSS at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IIEF EF at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8 | Baseline, Week 4; Baseline, Week 8 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | percentage of yes responses | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01937871/outcomes