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 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00429806
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women,
* Experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity,
* Women having a low maturation index and a vaginal pH above 5,
* Endometrial thickness of 4 mm or less at transvaginal ultrasonography,
* Body weight within 18.5 and 32.0 according to body mass index.
Exclusion Criteria:
* Undiagnosed abnormal genital bleeding,
* Active or history of thromboembolic disease,
* Significant metabolic or endocrine disease,
* Significant complication on previous hormonal therapy,
* Use of hormonal implants within 6 months prior to study entry,
* Use of oral estrogen, progestin or DHEA in the 8 weeks prior to baseline,
* Use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline,
* Chronic use of corticosteroids,
* Hypertension not controlled by standard therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00429806
Study Brief:
Protocol Section:
NCT00429806