Trial · NCT01080300
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
NCT01080300, Phase 3, Completed, Depomed; results first posted 2014-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women. Trials, record NCT01080300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01080300
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
- NCT number
- NCT01080300
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- Depomed
- Conditions
- Hot Flashes
- Interventions
- Gabapentin Extended Release, Placebo
- First posted
- 2010-03-04
- Last updated
- 2020-05-01
- Results first posted
- 2014-03-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. |
| 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 | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. |
| 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 | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 24 of the efficacy treatment period compared with Baseline. |
| 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 | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 24 of the efficacy treatment period compared with Baseline. |
| Secondary | Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Week 12 and Week 24 | Proportion of patients who were categorized as "very much" or "much improved" for PGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved". |
| Secondary | Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Week 12 and Week 24 | Proportion of patients who were categorized as "very much" or "much improved" in CGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved". |
| 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 | |
| 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 | |
| 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 | Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference) |
| 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 | Insomnia Severity Index (ISI) scored on 4-point Likert-scales ('0' not at all - '4' extremely) for 7 sub-categories. Final score is sum of each sub-category generating a total sleep quality score (0-28). Minimum value = 0, maximum value = 28 (Lower scores indicate better outcome (ie, less severity)). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | G-ER 1800 mg | Baseline LOCF Average Daily Frequency at Week 4 | -6.72 | 95% Confidence Interval -7.24 to -6.19 | hot flashes |
| 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. | Sugar Pill | Baseline LOCF Average Daily Frequency at Week 4 | -5.01 | 95% Confidence Interval -5.54 to -4.49 | hot flashes |
| 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. | G-ER 1800 mg | Baseline LOCF Average Daily Frequency at Week 12 | -7.64 | 95% Confidence Interval -8.21 to -7.07 | hot flashes |
| 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. | Sugar Pill | Baseline LOCF Average Daily Frequency at Week 12 | -6.50 | 95% Confidence Interval -7.07 to -5.94 | hot flashes |
| 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. | G-ER 1800 mg | Baseline LOCF Average Daily Severity at Week 4 | -0.42 | 95% Confidence Interval -0.51 to -0.33 | scores on a scale |
| 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. | Sugar Pill | Baseline LOCF Average Daily Severity at Week 4 | -0.22 | 95% Confidence Interval -0.31 to -0.13 | scores on a scale |
| 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. | G-ER 1800 mg | Baseline LOCF Average Daily Severity at Week 12 | -0.65 | 95% Confidence Interval -0.77 to -0.52 | scores on a scale |
| 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. | Sugar Pill | Baseline LOCF Average Daily Severity at Week 12 | -0.46 | 95% Confidence Interval -0.58 to -0.34 | scores on a scale |
| 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. | G-ER 1800 mg | -8.99 | 95% Confidence Interval -9.71 to -8.27 | hot flashes | |
| 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. | Sugar Pill | -7.91 | 95% Confidence Interval -8.62 to -7.19 | hot flashes |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | G-ER 1800 mg | 300 | |
| Overall Study | STARTED | Sugar Pill | 295 | |
| Overall Study | COMPLETED | G-ER 1800 mg | 206 | |
| Overall Study | COMPLETED | Sugar Pill | 191 | |
| Overall Study | NOT COMPLETED | G-ER 1800 mg | 94 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 104 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | G-ER 1800 mg | 38 | 300 | 44 |
| other | Dizziness | Nervous system disorders | Sugar Pill | 10 | 295 | 10 |
| other | Headache | Nervous system disorders | G-ER 1800 mg | 28 | 300 | 28 |
| other | Headache | Nervous system disorders | Sugar Pill | 24 | 295 | 25 |
| other | Somnolence | Nervous system disorders | G-ER 1800 mg | 18 | 300 | 18 |
| other | Somnolence | Nervous system disorders | Sugar Pill | 8 | 295 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | G-ER 1800 mg | 18 | 300 | 18 |
| other | Upper respiratory tract infection | Infections and infestations | Sugar Pill | 11 | 295 | 14 |
| serious | Anaemia | Blood and lymphatic system disorders | G-ER 1800 mg | 1 | 300 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Sugar Pill | 0 | 295 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | G-ER 1800 mg | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | G-ER 1800 mg | 102 | 300 |
| Total, other adverse events | Sugar Pill | 53 | 295 |
| Total, serious adverse events | G-ER 1800 mg | 4 | 300 |
| Total, serious adverse events | Sugar Pill | 7 | 295 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24149930 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| G-ER 1800 mg vs Sugar Pill: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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