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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT01647360
Eligibility Criteria:
Inclusion Criteria
* Females aged 18 to 45 years
* Subjects presenting with Heavy Menstrual Bleeding (HMB)
* Subjects with Pictorial Blood Assessment Chart (PBAC) score of 100 or more
* Subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial
Exclusion Criteria
* Subjects with structural or organic pathology as an underlying cause of HMB.
* Subjects with hypersensitivity to dydrogesterone
* Known or suspected progestogen dependent neoplasms
* Subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause
* Subjects with acute or chronic liver disease
* Patients with depressive illness
* Subjects who are known to have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Nursing mothers
* Use of any other medication for uterine bleeding (including but not limited to progesterone, oral contraceptive pills, tranexamic acid etc)
* Use of Non-Steroidal Anti inflammatory Drugs (NSAIDs)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01647360
Study Brief:
Protocol Section:
NCT01647360