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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT01862861
Eligibility Criteria:
Inclusion Criteria:
* Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.
* Participants must be starting a new regimen of bioidentical hormone replacement therapy.
* Participants must be expected to receive therapy for at least 12 weeks.
* Participants must be between 30 and 65 years of age.
* Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
Exclusion Criteria:
* Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
* Participants must not be pregnant or breastfeeding women.
* Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.
* Participants must not be using another bioidentical hormone at the time of enrollment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01862861
Study Brief:
Protocol Section:
NCT01862861