Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopaus… (NCT02040532) | Clinical Trial Compass
CompletedNot Applicable
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
United States32 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Tolerability of Gabapentin
Timeframe: Baseline, Week 4 visit, and study completion at 7 weeks
2
Reason for Non-tolerability and Discontinuation of Gabapentin
Timeframe: Baseline, Week 4 Visit, and study completion at 7 weeks
3
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime
Timeframe: Baseline, study completion at 7 weeks
4
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime