Trial · NCT01021553
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation | Up to Week 8 | Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). |
| Secondary | Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation | Up to Week 8 | Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). |
| Secondary | Mean IELT Compared After the First Dose of Study Drug or Placebo | Up to Week 8 | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). |
| Secondary | Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation | Baseline and up to Week 8 | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included. |
| Secondary | Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo | Baseline and Week 4 | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296 | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization | The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of GSK557296 | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization | The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. |
| Secondary | Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296 | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization | The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. |
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to follow up (post treatment 48 hours) | SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position. |
| Secondary | Mean Change From Baseline in Heart Rate | Baseline and up to follow up (post treatment 48 hours) | Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position. |
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Values | Baseline and up to follow up (post treatment 48 hours) | ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia's formula (QTc \[Fridericia\]), QT duration corrected for heart rate by Bazett's formula (QTc \[Bazett\]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant's Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. |
| Secondary | Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) | Baseline and up to follow up (post treatment 48 hours) | Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value. |
| Secondary | Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) | Baseline and up to follow up (post treatment 48 hours) | Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value. |
| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline and up to follow up (post treatment 48 hours) | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication. |
| Secondary | Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling | Up to Week 8 | The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models. |
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.
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