Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT02040532
Eligibility Criteria:
Inclusion Criteria:
1. Females aged 40-65 years
2. Postmenopausal or perimenopausal
3. Having bothersome hot flashes
4. Having some bothersome hot flashes during the night
5. Insomnia or problems sleeping
6. In general, good health
7. Signed informed consent
Exclusion Criteria:
1. Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)
2. Recent use of any prescribed therapy that is taken specifically for hot flashes
3. Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes
4. Recent use of any prescribed medications with known hot flash efficacy
5. Known hypersensitivity or contraindications (reasons not to take) to gabapentin
6. Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
7. Recent drug or alcohol abuse
8. Lifetime diagnosis of psychosis or bipolar disorder
9. Suicide attempt in the past 3 years or any current suicidal ideation
10. Current major depression (assessed during screening)
11. Pregnancy, intending pregnancy, or breast feeding
12. History of:
1. Renal insufficiency or a kidney disorder
2. Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy
13. Any unstable medical condition
14. Working a night/rotating shift
15. Abnormal screening blood tests
16. Current participation in another drug trial or intervention study
17. Inability or unwillingness to complete the study procedures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02040532
Study Brief:
Protocol Section:
NCT02040532