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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01769820
Eligibility Criteria:
Inclusion Criteria:
* Complaint of HMB, including women with fibroids
* Pre-menopausal
* Age 18 years and over
* Describing menstrual cycles every 21- 42 days
* Provide written informed consent prior to any study related procedures
* If of childbearing potential either agree to practice a non-hormonal method of contraception for duration of study or have a partner with a vasectomy
* Workup (Study 1 or 2)- MBL for single screening period is \>= 50mL
* Adaptive Trial (Study 3)- average MBL for two screening menstrual collections is \>= 50mL
Exclusion Criteria:
* Currently breast-feeding
* History or current uterus, cervix, ovarian or breast cancer
* Known severe coagulation disorder
* Glucocorticoid treatment or sex steroid administration by any route in previous 1 month
* Taking prohibited medication -
* Thyroid, renal or liver dysfunction
* Diabetes mellitus
* Treated moderate/severe hypertension
* Psychotic depressive illness
* Rare hereditary galactose intolerance, lactase deficiency or glucose galactose malabsorption (due to lactose content of trial medication)
* Has a problem with alcohol or drug abuse
* Has a mental condition rendering her unable to understand the nature and scope of the study
* Participation in treatment phase in any earlier DexFEM study (1 or 2)
* Is currently enrolled in an investigational drug or device study or participated in such a study within the previous 30 days and is still in exclusion period
* workup study 1, only, an additional exclusion criterion of any contra-indication to MRI
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01769820
Study Brief:
Protocol Section:
NCT01769820