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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05903820
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal, defined as final menstrual cycle more than 1 years prior to inclusion and FSH\>30 IU/L
* Final menstrual cycle \< 10 years prior to inclusion
Exclusion Criteria:
* Contra-indication for estrogen and/or progesterone therapy
* First-grade family member with inherited thrombophilia or history of venous thromboembolism under the age of 60 years
* Hysterectomy
* Premature menopause (menopause age \<40 years)
* Known hypersensitivity to the excipients in the estradiol patch or progesterone capsule
* Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) in the past 12 months
* Presence or history of any clinically relevant metabolic, endocrinological, hepatic, renal, cardiovascular, gastrointestinal, or respiratory conditions, history of bone disease or bone marrow disease, known vitamin D deficiency (25-OH vitamin D \<30 nmol/L)
* Recent fracture (\<12 months)
* BMI \<20 or BMI ≥30
* Use of drugs including herbal medicine known to affect bone metabolism (e.g. corticosteroids) or to interfere with cytochrome P450 enzyme (CYP) pathways. Exceptions are occasional use of paracetamol, ibuprofen, acetylsalicylic acid or topical medication
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT05903820
Study Brief:
Protocol Section:
NCT05903820