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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT03272568
Eligibility Criteria:
Inclusion Criteria:
* Females of reproductive age who experience monthly menstrual bleedings
* Female Hemophilia A or B carrier (heterozygote, lyonized or Turner's Syndrome)
* FVIII or FIX activity ≤60% at time of the study
* Baseline Pictorial Bleeding Assessment Chart \>150 mean at time of recruitment
* Negative pregnancy test at time of enrollment
* Both female and her male partner have agreed to use an acceptable barrier method of birth control (e.g., diaphragm, cervical cap, male condom, female condom, and spermicidal foam, sponges, and film) throughout the duration of this study (for sexually active participants)
Exclusion Criteria:
* Has not reached menarche
* Menopause: natural or induced by surgical/medical treatment
* Pregnant or breasfeeding
* Female or her male partner refuses to use barrier method of birth control (for sexually active)
* Current use of any of the following contraceptives (copper IUD, oral combined, Progestin-only including but not limited to: Provera, Aygestin, Nexplanon, Implanon, Depo Provera, Mirena IUD)
* VWF:Ag or VWF:RCo \<40%
* Diagnosis of a qualitative platelet disorder
* Personal history of thrombosis or superficial thrombosis
* First degree relative with a history of thrombosis
* Personal history of concomitant bleeding or clotting disorder
* Cigarette smoker
* Willing to avoid taking an anti-fibrinolytic agent (amicar, transexamic acid, lysteda) during the trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
55 Years
Study:
NCT03272568
Study Brief:
Protocol Section:
NCT03272568