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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00195520
Eligibility Criteria:
Inclusion Criteria:
* Intact uterus
* Generally health postmenopausal women 45 to 60 years of age, inclusive
* Sexually active
* No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.
Exclusion Criteria:
* Known or suspect estrogen-dependent neoplasia
* Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
* Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT00195520
Study Brief:
Protocol Section:
NCT00195520