Trial · NCT02040532
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
NCT02040532, Not applicable, Completed, Massachusetts General Hospital; results first posted 2017-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women. Trials, record NCT02040532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02040532
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
- NCT number
- NCT02040532
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 32 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Menopause, Hot Flashes, Vasomotor Disturbance
- Interventions
- Gabapentin
- First posted
- 2014-01-20
- Last updated
- 2019-08-07
- Results first posted
- 2017-02-27
- Limitations and caveats
* lack of control group (important given that previous VMS medication trials have indicated modest placebo response rates)~* small sample size~* relatively low rate of completion (6 of 26 subjects who received medication did not reach study endpoint)
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerability of Gabapentin | Baseline, Week 4 visit, and study completion at 7 weeks | Tolerability of gabapentin was assessed by self-report at the week 1, week 4 and week 7 contacts by asking participants to complete the SAFTEE-SI and CPFQ questionnaires and prompting subjects to report any adverse events at each study visit. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from 300-mg to 600-mg and to remain on the higher dose for the duration of the trial. |
| Primary | Reason for Non-tolerability and Discontinuation of Gabapentin | Baseline, Week 4 Visit, and study completion at 7 weeks | Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion |
| Primary | Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime | Baseline, study completion at 7 weeks | Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities. |
| Primary | Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime | Baseline, study completion at 7 weeks | Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities. |
| Primary | Severity of Insomnia | Baseline, study completion at 7 weeks | Severity of insomnia was measured throughout the study using the Insomnia Severity Index (ISI) .The ISI is a 7-item scale that evaluates the severity of insomnia retrospectively over the past week. The scale is more specific to insomnia symptoms than the Pittsburgh scale (PSQI), which focuses more broadly on overall sleep quality. The ISI score ranges from a minimum of 0 to 28. A score of 0-7=no clinically significant insomnia, 8-14=subthreshold insomnia, 5-21=clinical insomnia (moderate severity), 22-28=clinical insomnia (severe), with higher values indicating more severe insomnia. |
| Primary | Sleep Quality and Disturbances Over Past Month | Baseline, study completion at 7 weeks | Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
| Other | Quality of Life-Overall | Baseline, study completion at 7 weeks | Quality of life-Overall was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16-item self-report questionnaire that assesses enjoyment of and satisfaction with life. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70 with higher scores indicating higher quality of life enjoyment and satisfaction. |
| Other | Quality of Life-Menopause Specific | Baseline, study completion at 7 weeks | The Quality of life-Menopause specific is assessed by the Menopause Specific Quality of Life (MENQOL). The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tolerability of Gabapentin | Baseline, Week 4 visit, and study completion at 7 weeks | All 26 participants who initiated treatment with gabapentin were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Reason for Non-tolerability and Discontinuation of Gabapentin | Baseline, Week 4 Visit, and study completion at 7 weeks | Four subjects initiated treatment with gabapentin but discontinued prior to study completion due to side effects. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime | Baseline, study completion at 7 weeks | Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit. | vasomotor symptoms (VMS) per day | MEAN |
| PRIMARY | Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime | Baseline, study completion at 7 weeks | Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit. | vasomotor symptoms (VMS) per night | MEAN |
| PRIMARY | Severity of Insomnia | Baseline, study completion at 7 weeks | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had ISI data at baseline and study completion. | scores on a scale | MEAN |
| PRIMARY | Sleep Quality and Disturbances Over Past Month | Baseline, study completion at 7 weeks | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had PSQI data at baseline and study completion. | scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Quality of Life-Overall | Baseline, study completion at 7 weeks | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had Q-LES-Q data at baseline and study completion. | scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Quality of Life-Menopause Specific | Baseline, study completion at 7 weeks | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had MENQOL data at baseline and study completion. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tolerability of Gabapentin | Open-label Gabapentin | # of subjects who tolerated gabapentin | 22 | Participants | |
| Tolerability of Gabapentin | Open-label Gabapentin | # of subjects who did not tolerate gabapentin | 4 | Participants | |
| Reason for Non-tolerability and Discontinuation of Gabapentin | Open-label Gabapentin | Morning sickness and Nausea | 3 | Participants | |
| Reason for Non-tolerability and Discontinuation of Gabapentin | Open-label Gabapentin | Mild Rash | 1 | Participants | |
| Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime | Open-label Gabapentin | mean VMS per day at baseline | 4.1 | Full Range 0.2 to 8.5 | vasomotor symptoms (VMS) per day |
| Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime | Open-label Gabapentin | mean VMS per day at study completion | 2.2 | Full Range 0 to 6.7 | vasomotor symptoms (VMS) per day |
| Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime | Open-label Gabapentin | mean VMS per night at baseline | 3.5 | Full Range 1.5 to 8.0 | vasomotor symptoms (VMS) per night |
| Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime | Open-label Gabapentin | mean VMS per night at study completion | 1.1 | Full Range 0 to 3.9 | vasomotor symptoms (VMS) per night |
| Severity of Insomnia | Open-label Gabapentin | mean ISI score at baseline | 15.6 | Full Range 8 to 24 | scores on a scale |
| Severity of Insomnia | Open-label Gabapentin | mean ISI score at study completion | 6.0 | Full Range 0 to 18 | scores on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-label Gabapentin | 32 | |
| Overall Study | Received at Least One Dose of Medication | Open-label Gabapentin | 26 | |
| Overall Study | COMPLETED | Open-label Gabapentin | 20 | |
| Overall Study | NOT COMPLETED | Open-label Gabapentin | 12 |
Source ClinicalTrials.gov
Adverse events17
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 | Headaches | Nervous system disorders | Open-label Gabapentin | 9 | 26 | |
| other | Sweating | Respiratory, thoracic and mediastinal disorders | Open-label Gabapentin | 8 | 26 | |
| other | Hot flashes | Pregnancy, puerperium and perinatal conditions | Open-label Gabapentin | 7 | 26 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Open-label Gabapentin | 6 | 26 | |
| other | Feeling tired/fatigue | General disorders | Open-label Gabapentin | 6 | 26 | |
| other | Feeling drowsy during the day | General disorders | Open-label Gabapentin | 8 | 26 | |
| other | Problems falling asleep | General disorders | Open-label Gabapentin | 4 | 26 | |
| other | Weight gain | Metabolism and nutrition disorders | Open-label Gabapentin | 4 | 26 | |
| other | Stomach/abdominal discomfort | Gastrointestinal disorders | Open-label Gabapentin | 4 | 26 | |
| other | Gas | Gastrointestinal disorders | Open-label Gabapentin | 4 | 26 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Gabapentin | ||
| Total, other adverse events | Open-label Gabapentin | 11 | 26 |
| Total, serious adverse events | Open-label Gabapentin | 0 | 26 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AG032700 | MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMS | COHEN, LEE S; JOFFE, HADINE | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE ON AGING | 2008 to 2012 |
Source NIH RePORTER
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/NCT02040532
GET https://conductscience.org/api/trials/v1/NCT02040532/registered