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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT03547661
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe PMS
* Between 18 and 45 years of age
* A regular menstrual cycle, i.e., max. +/- 3 days of difference of cycle range
* Menstrual cycle range not longer than 31 or shorter than 24 days
* Participants have a general practioner or gynaecologist to consult
* At least one premenstrual symptom causes the desire for a PMS treatment
Exclusion Criteria:
* Brest feeding at the moment or during the last three months
* Pregnancy
* Failing menstruation onset in the course of two consecutive menstrual cycles
* An essential mental or somatic disease
* Drug or massive alcohol intake or of other psychoactive substances
* Uptake of a new medication within the last 30 days
* Menopause, premenopausal strain or amenorrhoea
* Allergy of one of the ingredients of the placebo dragées (P-Dragees rosa Lichtenstein)
* Women who are surgically sterilised, hysterectomised, or ovariectomised
* BMI above 30
* Actual or recent participation in psychotherapy due to premenstrual symptoms
* Parallel participation in another study with investigational drugs or participation in another PMS study within the last three months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03547661
Study Brief:
Protocol Section:
NCT03547661