Trial · NCT01080300
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | Baseline, Week 4, and Week 12 | Intent-to-treat (ITT) Population | hot flashes | LEAST_SQUARES_MEAN |
| PRIMARY | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | Baseline, Week 4, and Week 12 | Intent-to-treat (ITT) Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | Baseline, Week 24 | Completer Population | hot flashes | LEAST_SQUARES_MEAN |
| SECONDARY | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | Baseline, Week 24 | Completer Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Week 12 and Week 24 | Intent-to-treat (ITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Week 12 and Week 24 | Intent-to-treat (ITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes | Baseline, Week 12, and Week 24 | Intent-to-treat (ITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes | Baseline, Week 12, and Week 24 | Intent-to-treat (ITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score. | Baseline, Week 4, Week 12, and Week 24 | Intent-to-treat (ITT) Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period. | Baseline, Week 4, Week 12, and Week 24 | Intent-to-treat (ITT) Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period. | Baseline, Week 4, Week 12, and Week 24 | Intent-to-treat (ITT) Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS). | Week 4, Week 12, Week 24/Early Termination, Week 28 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT01080300/outcomes