N/A
N=32
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Menopause · Hot Flashes · Vasomotor Disturbance
Bottom Line
View on ClinicalTrials.gov: NCT02040532 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Tolerability of Gabapentin — 22; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gabapentin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability of Gabapentin |
22; 4 | — |
| PRIMARY Reason for Non-tolerability and Discontinuation of Gabapentin |
3; 1 | — |
| PRIMARY Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime |
4.1; 2.2 | — |
| PRIMARY Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime |
3.5; 1.1 | — |
| PRIMARY Severity of Insomnia |
15.6; 6.0 | — |
| PRIMARY Sleep Quality and Disturbances Over Past Month |
9.6; 4.9 | — |
Summary
The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. We hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.
Eligibility Criteria
Inclusion Criteria
- Females aged 40-65 years
- Postmenopausal or perimenopausal
- Having bothersome hot flashes
- Having some bothersome hot flashes during the night
- Insomnia or problems sleeping
- In general, good health
- Signed informed consent
Exclusion Criteria
- Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)
- Recent use of any prescribed therapy that is taken specifically for hot flashes
- Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes
- Recent use of any prescribed medications with known hot flash efficacy
- Known hypersensitivity or contraindications (reasons not to take) to gabapentin
- Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
- Recent drug or alcohol abuse
- Lifetime diagnosis of psychosis or bipolar disorder
- Suicide attempt in the past 3 years or any current suicidal ideation
- Current major depression (assessed during screening)
- Pregnancy, intending pregnancy, or breast feeding
- History of:
- Renal insufficiency or a kidney disorder
- Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy
- Any unstable medical condition
- Working a night/rotating shift
- Abnormal screening blood tests
- Current participation in another drug trial or intervention study
- Inability or unwillingness to complete the study procedures
Data sourced from ClinicalTrials.gov (NCT02040532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.