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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT00221312
Eligibility Criteria:
Inclusion Criteria:
* Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.
Exclusion Criteria:
* Women should not be on hormone replacements, oral contraceptives, or bone mineral enhancing medications (bisphosphonates, selective estrogen receptor modulators \[SERM's\], parathyroid hormone \[PTH\], calcitriol, fluorides)
* They should not have any abnormalities of the esophagus which delay esophageal emptying
* They should not have hypocalcemia or severe kidney disease
* Their bone mineral density (T-score) should not be greater than 2 standard deviations.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
54 Years
Study:
NCT00221312
Study Brief:
Protocol Section:
NCT00221312