gabapentin and Menopause

gabapentin has been researched along with Menopause in 43 studies

Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.
gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome.

Menopause: The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age.

Research

Studies (43)

Authors

Clinical Trials (12)

Trial Overview

Trial Outcomes

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 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. (NCT01080300)
Timeframe: Baseline, Week 24

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.

"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." (NCT01080300)
Timeframe: Baseline, Week 24

Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.

Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference) (NCT01080300)
Timeframe: Baseline, Week 4, Week 12, and Week 24

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.

"4 sub-categories each scored individually: Minimum value = 1, maximum value = 8.~Overall summary score was mean of the 4 sub-category scores (minimum = 1 and maximum = 8).~Lower scores indicate better outcome (ie, less severity)" (NCT01080300)
Timeframe: Baseline, Week 4, Week 12, and Week 24

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.

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)). (NCT01080300)
Timeframe: Baseline, Week 4, Week 12, and Week 24

Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.

"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." (NCT01080300)
Timeframe: Week 12 and Week 24

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 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. (NCT01080300)
Timeframe: Baseline, Week 4, and Week 12

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 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." (NCT01080300)
Timeframe: Baseline, Week 4, and Week 12

Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.

"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." (NCT01080300)
Timeframe: Week 12 and Week 24

Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes

(NCT01080300)
Timeframe: Baseline, Week 12, and Week 24

Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes

(NCT01080300)
Timeframe: Baseline, Week 12, and Week 24

Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).

"Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects were classified as 0=no suicidal ideation or 1=suicidal ideation. Outcome Measure is number of participants with or without suicidal ideation.~Higher counts without suicidal ideation = better outcome." (NCT01080300)
Timeframe: Week 4, Week 12, Week 24/Early Termination, Week 28

Quality of Life-Menopause Specific

"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." (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Quality of Life-Overall

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. (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Severity of Insomnia

"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." (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Sleep Quality and Disturbances Over Past Month

"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." (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime

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. (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime

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. (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4

"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question." (NCT00786188)
Timeframe: Week 4

Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4

"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 335.~The percentage of participants who had a change from baseline in the total score at Week 4 is reported below." (NCT00786188)
Timeframe: Week 4

Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8

The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated. (NCT00786188)
Timeframe: Week 8

Change From Baseline in Climacteric Symptoms at Week 8

"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below." (NCT00786188)
Timeframe: Week 8

Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8

"A scale was not used for this measurement.~Composite scores of hot flashes were calculated by using the following formula:~CS = (2 • Fm + 3 • Fs)~Where:~CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score." (NCT00786188)
Timeframe: Week 4 and Week 8

Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8

Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms. (NCT00786188)
Timeframe: Week 4 and Week 8

Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8

"Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).~The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.~The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8." (NCT00786188)
Timeframe: Week 8

Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8

"The number of hot flashes reported in the result table are:~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week." (NCT00786188)
Timeframe: Week 4 and Week 8

Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8

"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.~SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)~Where:~SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score." (NCT00786188)
Timeframe: Week 4 and Week 8

Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8

The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. (NCT00786188)
Timeframe: Week 4 and Week 8

Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8

"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.~The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question." (NCT00786188)
Timeframe: Week 4 and Week 8

Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.

"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:~Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%." (NCT01101841)
Timeframe: Week 24

Assessment of Mood

"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below." (NCT01101841)
Timeframe: Week 4 and Week 12

BMI Change From Baseline (kg/m2), Median

"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index." (NCT01101841)
Timeframe: Week 4 and Week 12

Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median

The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12. (NCT01101841)
Timeframe: Week 4 and Week 12

Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median

"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below." (NCT01101841)
Timeframe: Week 4 and Week 12

Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median

"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline." (NCT01101841)
Timeframe: Week 4 and Week 12

Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median

"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12." (NCT01101841)
Timeframe: Week 4 and Week 12

Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median

"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12." (NCT01101841)
Timeframe: Week 4 and Week 12

Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median

"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below." (NCT01101841)
Timeframe: Week 4 and Week 12

Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median

"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below." (NCT01101841)
Timeframe: Week 4 and Week 12

Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression

"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12." (NCT01101841)
Timeframe: Week 4 and Week 12

Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)

"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question." (NCT01101841)
Timeframe: Week 4 and Week 12

Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.

"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12" (NCT01101841)
Timeframe: Week 4 and Week 12

Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.

"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes" (NCT01101841)
Timeframe: Week 4 and Week 12

Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)

"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6." (NCT01101841)
Timeframe: Week 4 and Week 12

Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.

"Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of Very Much Improved Or Much Improved Or Minimally Improved.~Non Responders: Subjects with a Score of No Change Or Minimally Worse Or Much Worse Or Very Much Worse." (NCT01101841)
Timeframe: Week 4 and Week 12

Percentage of Responders

Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below. (NCT01101841)
Timeframe: Week 4 and Week 12

Hot Flash Related Daily Interference Score (HFRDIS)

The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks. (NCT00711529)
Timeframe: Week 8

Hot Flash Related Daily Interference Score (HFRDIS)

The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point. (NCT00711529)
Timeframe: Week 4

Hot Flash Related Daily Interference Score (HFRDIS)

The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization). (NCT00711529)
Timeframe: Baseline

Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Baseline

Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Week 4

Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Week 8

Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark." (NCT00711529)
Timeframe: Week 4

Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries." (NCT00711529)
Timeframe: Baseline

Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark." (NCT00711529)
Timeframe: Week 8

Reviews

29 reviews available for gabapentin and Menopause

Trials

4 trials available for gabapentin and Menopause

Other Studies

10 other studies available for gabapentin and Menopause