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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT01160159
Eligibility Criteria:
Inclusion Criteria:
* healthy volunteers
* 18-45 years old women of child bearing age
* Without any hormonal contraception nor any hormone treatment since at least 3 months
* Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking\> 5 cigaret )
* Patient who have signed an inform consent
* With no thrombophilia : normal sample for factor V and II mutations
* Willing to participate to the study
* Adherent to health insurance
* Previous Clinical examination
* women with thrombophilia
* 18-45 years old women of child bearing age
* Without any hormonal contraception nor any hormone treatment since at least 3 months
* Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking\> 5 cigaret )
* Patient who have signed an inform consent
* With thrombophilia : normal sample for factor V and II mutations
* Willing to participate to the study
* Adherent to health insurance
* Previous Clinical examination
Exclusion Criteria:
* Women under hormonal contraception or who have stopped it less than 3 months ago
* Women under anticoagulant
* Arterial risk factor : HTA, diabetes, dyslipemia, obesity(BMI\>30), including smoking\> 5 cigarets ), metabolic syndrome, antiphospholipids/anticoagulant antibody, SLE
* History of coronaropathy or of stroke
* Pregnant women or willing to conceive
* Severe liver disease
* Women of less than 18y or older than 45y
* Severe liver diseases
* Patient not willing to sign up the inform consent
* Patient refusal to participate
* Endometrial cancer
* Unexplored bleeding
* Women not willing to participate or included in another trial
* Woman with another thrombophilic disorder (ATIII, protein C, S, history of VTE without any biological thrombophilic disorder.
* Women with at least one of the following treatment and who cannot stop it 48h before the arterial investigations.
* Gynergen caffeine
* NOCERTONE® oxetorone
* SIBÉLIUM®flunarizine
* VIDORA®indoramine
* SANMIGRAN® 0,50 mg pizotifen
* woman under propranolol AVLOCARDYL® 40 mg \*AVLOCARDYL® LP 160 mg
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01160159
Study Brief:
Protocol Section:
NCT01160159