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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT00463450
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Postmenopausal status (amenorrhea for at least 12 months)
* 45 - 65 years of age
* Application of estrogen or cyclic estrogen/progestin preparation other than the study medication for at least 6 months prior to Visit 1
* Relevant impairment of well-being and mood inspite of estrogen therapy (confirmed by questionnaire scores)
* BMI\<33kg/m2
Exclusion Criteria:
* Uterine bleeding of unknown etiology within the last 2 years
* Previous or existing or suspected carcinoma of the breast
* Any malignant disease in the last 5 years
* Endometrial double layer thickness \> 5 mm
* History of thromboembolic events or existing thromboembolic processes
* Prior hormone replacement therapy with androgens within 12 months prior to Visit 1
* Major life events within the last 12 months prior to Visit 1
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT00463450
Study Brief:
Protocol Section:
NCT00463450