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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00779532
Eligibility Criteria:
Inclusion Criteria:
* Female (aged 18-50 years) with a body mass index (BMI) of 17 \<= BMI \<= 29 kg/m\^2 at screening;
* Able and willing to use non-hormonal contraceptives during the trial from at least 2 weeks prior to Day 1 up to and including follow-up;
* Able and willing to sign the Informed Consent Form prior to screening evaluations;
* Subject is in a good age-appropriate healthy condition as established by medical history, physical examination, cardiac monitoring, electrocardiogram, results of biochemistry, hematology and urinalysis testing within 4 weeks prior to treatment as judged by the investigator;
* Normal 12-lead automatic ECG at screening and admission;
* Subject has a normal blood pressure at screening and admission;
* Subject smokes less than 5 cigarettes or equivalent per day and is capable of not smoking from 48 hours prior drug administration on Day -1 and Day 14 until the last ECG has been taken on respectively Day 1 and Day 15;
* Able to refrain from all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) from 48 hours prior to drug administration on Day -1 and Day 14 until the last ECG has been taken on respectively Day 1 and Day 15;
* Able to refrain from alcohol containing beverages from 24 hours prior to drug administration on Day -1 and Day 14 until the last ECG has been taken on respectively Day 1 and Day 15;
* Able to refrain from all use of grapefruit containing products from 14 days prior to first NOMAC-E2 dosing until the last ECG has been taken;
* Easy venous accessibility.
Exclusion Criteria:
* History of sensitivity/idiosyncrasy to the applied drugs or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past
* Use of any drug or substance within one week and hormonal contraception within 2 weeks prior to the first treatment day, except for paracetamol or topical medication without systemic exposure
* Present use or use during 2 months prior to the start of treatment of any drugs interfering with the trial medication;
* Clinically relevant history or presence of any medical disorder, potentially interfering with this trial (according to the investigator)
* Known or suspected pregnancy
* History of/or current abuse of drugs or alcohol or solvents, or positive drug or alcohol screen at screening and admission, as judged by the (sub-)investigator
* Positive test result on hepatitis B surface antigen, hepatitis C antibody, or HIV 1/2 serology
* Participation in an investigational drug trial within 90 days prior to treatment
* Donation of blood within 90 days prior to treatment
* Contraindications for contraceptive steroids
* Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
* Present use or use within one month prior to treatment or within 10 half-lives in case the half-life \> 3 days of any agent that is known to prolong the QT/QTc interval
* History of/or current risk factors for Torsade de Pointes (TdP) or life-threatening ventricular arrhythmia (e.g. heart failure, hypokaliemia, hypomagnesaemia, hypocalcaemia, family history of long or short QT syndrome, loss of consciousness)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00779532
Study Brief:
Protocol Section:
NCT00779532