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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT00323635
Eligibility Criteria:
Inclusion Criteria:
1. Post-menopausal women, age 45 to 65 years old.
2. No menses for at least 6 months before the study start.
3. Have at least 14 episodes of nocturia per week.
4. Have at least 4 hot flashes daily.
5. Overall good health, as evidenced by a letter from the primary care provider.
6. Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
7. Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.
Exclusion Criteria:
1. Use of anti-cholinergic, hypnotic or sedating drugs
2. Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.
3. A urinary tract infection within a month of study start.
4. Undiagnosed abnormal vaginal bleeding.
5. Benign or malignant liver disease.
6. History or presence of chronic alcoholism or medication addiction within the past 5 yrs.
7. An acute systemic infection within seven days before the study start.
8. Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.
9. History of shift work within the past 6 months.
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Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT00323635
Study Brief:
Protocol Section:
NCT00323635