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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00729469
Eligibility Criteria:
Inclusion Criteria:
* Naturally or surgically menopausal
* Moderate or severe symptoms of vaginal atrophy
* 5% or fewer superficial cells in maturation index of vaginal smear
* Vaginal pH greater than 5.0
* Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization
Exclusion Criteria:
* Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
* Current vaginal infection requiring medication
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.
uterine or vaginal prolapse of Grade 2 or higher)
* Previous participation in any other ospemifene study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00729469
Study Brief:
Protocol Section:
NCT00729469