Trial · NCT00755417
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
NCT00755417, Phase 3, Completed, Depomed; results first posted 2012-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women. Trials, record NCT00755417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00755417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
- NCT number
- NCT00755417
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 541 participants, actual
- Lead sponsor
- Depomed
- Conditions
- Hot Flashes
- Interventions
- Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg, Placebo
- First posted
- 2008-09-19
- Last updated
- 2012-03-07
- Results first posted
- 2012-03-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | From baseline to 4 weeks | Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. |
| Primary | Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | Form baseline to 12 weeks | Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. |
| Primary | Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | From baseline to 4 weeks | Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe. |
| Primary | Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | From baseline to 12 weeks | Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | From baseline to 4 weeks | Moderate or severe hot flashes | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | Form baseline to 12 weeks | Moderate or severe hot flashes | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | From baseline to 4 weeks | Score on a numerical scale | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | From baseline to 12 weeks | Score on a numerical scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1200 mg | -6.8 | 95% Confidence Interval -7.37 to -6.13 | Moderate or severe hot flashes | |
| Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1800 mg | -7.3 | 95% Confidence Interval -7.89 to -6.71 | Moderate or severe hot flashes | |
| Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | Sugar Pill | -5.8 | 95% Confidence Interval -6.41 to -5.18 | Moderate or severe hot flashes | |
| Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1200 mg | -7.4 | 95% Confidence Interval -8.10 to -6.73 | Moderate or severe hot flashes | |
| Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1800 mg | -7.4 | 95% Confidence Interval -8.04 to -6.74 | Moderate or severe hot flashes | |
| Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | Sugar Pill | -6.9 | 95% Confidence Interval -7.53 to -6.18 | Moderate or severe hot flashes | |
| Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1200 mg | -0.5 | 95% Confidence Interval -0.68 to -0.41 | Score on a numerical scale | |
| Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1800 mg | -0.6 | 95% Confidence Interval -0.74 to -0.48 | Score on a numerical scale | |
| Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | Sugar Pill | -0.3 | 95% Confidence Interval -0.42 to -0.15 | Score on a numerical scale | |
| Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo | G-ER 1200 mg | -0.7 | 95% Confidence Interval -0.91 to -0.58 | Score on a numerical scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | G-ER 1200 mg | 174 | |
| Overall Study | STARTED | G-ER 1800 mg | 181 | |
| Overall Study | STARTED | Sugar Pill | 177 | |
| Overall Study | COMPLETED | G-ER 1200 mg | 112 | |
| Overall Study | COMPLETED | G-ER 1800 mg | 126 | |
| Overall Study | COMPLETED | Sugar Pill | 135 | |
| Overall Study | NOT COMPLETED | G-ER 1200 mg | 62 | |
| Overall Study | NOT COMPLETED | G-ER 1800 mg | 55 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 42 |
Source ClinicalTrials.gov
Adverse events66
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 | Back pain | Musculoskeletal and connective tissue disorders | G-ER 1200 mg | 4 | 174 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | G-ER 1800 mg | 5 | 181 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Sugar Pill | 9 | 177 | 9 |
| other | Dizziness | Nervous system disorders | G-ER 1200 mg | 41 | 174 | 41 |
| other | Dizziness | Nervous system disorders | G-ER 1800 mg | 35 | 181 | 35 |
| other | Dizziness | Nervous system disorders | Sugar Pill | 5 | 177 | 5 |
| other | Fatigue | General disorders | G-ER 1200 mg | 9 | 174 | 9 |
| other | Fatigue | General disorders | G-ER 1800 mg | 9 | 181 | 9 |
| other | Fatigue | General disorders | Sugar Pill | 3 | 177 | 3 |
| other | Flatulence | Gastrointestinal disorders | G-ER 1200 mg | 11 | 174 | 11 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | G-ER 1200 mg | ||
| Total, all-cause mortality | G-ER 1800 mg | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | G-ER 1200 mg | 148 | 174 |
| Total, other adverse events | G-ER 1800 mg | 167 | 181 |
| Total, other adverse events | Sugar Pill | 65 | 177 |
| Total, serious adverse events | G-ER 1200 mg | 2 | 174 |
| Total, serious adverse events | G-ER 1800 mg | 6 | 181 |
| Total, serious adverse events | Sugar Pill | 4 | 177 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00755417
GET https://conductscience.org/api/trials/v1/NCT00755417/events?page=2