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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT06584669
Eligibility Criteria:
Inclusion Criteria:
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Age: 20 - 50 years
* Sex: female
* Premenopausal
* Regular menstrual bleeding
* History of and presence of PMS symptoms of at least 6 months
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Exclusion Criteria:
* BMI: \< 19 kg/m2, ≥ 30 kg/m2
* Heavy smoker \>15 cigarettes / day
* Known pregnancy, breast feeding or intention to become pregnant during the course of the study
* No use of acceptable contraceptive method during the study
* Menstrual cycle lasting less than 24 / longer than 35 days
* Hormone treatment because of premenstrual symptoms
* Diagnosed premenstrual dysphoric disorder (PMDD), a severe form of PMS
* Regular consumption of omega-3 fatty acids (e.g. nutritional supplements) within previous 3 months or during the study course
* Fish consumption of more than 1 serving of fatty fish (e.g herring, mackerel, salmon) per week
* Relevant allergy or known hypersensitivity against compounds of the study preparations
* Unstable medical illness or relevant history or presence of any medical disorder, potentially interfering with this study (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke in the last 6 months or psychiatric disorders / psychoactive medication)
* Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
* Intake of medication potentially interfering with this study
* Known malabsorption / maldigestion
* Drug-, alcohol- and medication abuses
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Blood donation within 2 weeks prior to study start (day 1) or during study
* Participation in any other clinical study within the last 30 days prior to study start or during the study
* Any other condition that, based on Investigator's judgement, makes the subject unfit for inclusion into study
* Anticipating any planned changes in lifestyle for the duration of the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT06584669
Study Brief:
Protocol Section:
NCT06584669