Trial · NCT00683800
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 | Baseline and Week 4 | Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4. | Hot Flushes | MEAN |
| PRIMARY | Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12 | Baseline and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Hot Flushes | MEAN |
| PRIMARY | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4 | Baseline and Week 4 | MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4. | Units on a Scale | MEAN |
| PRIMARY | Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12 | Baseline and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Units on a Scale | MEAN |
| PRIMARY | Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events | Baseline up to Month 12 | Safety population included all randomized participants who received at least 1 dose of study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes | Baseline and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes | Baseline, Week 4 and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes | Baseline, Week 4 and Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method. | Percentage of participants | NUMBER |
| SECONDARY | Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes | Week 12 | MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12 | Baseline, Month 6 and Month 12 | MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. | Hot Flushes | MEAN |
| SECONDARY | Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12 | Baseline, Month 6 and Month 12 | MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12 | Baseline and Week 12 | Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy Greene Climacteric Scale (GCS) assessment or at least 1 on therapy Patient Global Impression (PGI) assessment. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6 | Baseline and Month 6 | Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12 | Baseline and Month 12 | Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. | Units on a Scale | MEAN |
| SECONDARY | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12 | Week 12 | Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6 | Month 6 | Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12 | Month 12 | Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12 | Week 12 | MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6 | Month 6 | MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12 | Month 12 | MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale. | Percentage of Participants | NUMBER |
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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