A three months intake of soy lecithin phosphatidylserine/phosphatidic acid complex (PAS) and effects on the premenstrual syndrome (PMS)

Not Applicable

• Conditions: Premenstrual Syndrome; N94.3; Premenstrual tension syndrome

• Registration Number: DRKS00009005
• Lead Sponsor: ipogen Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-05
• Study Completion: 2017-05-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

PMS diagnosis;
Regular menstrual cycle with a constant cycle duration (25-35 days);
Easy access to computer and internet at home

Exclusion Criteria

Known allergies to ingredients of the test substance;
Any further psychiatric diseases (e.g. major depressive disorder) as assessed with the Mini-DIPS;
Current intake of any drugs besides thyroid medication (TSH values in the normal range, lab results not older than 12 months) and blood pressure medication (stable for 6 months);
Intake of nutritional supplements or homeopathic remedies within the two weeks prior to V1;
Any current / acute disease besides thyroid
Any disease besides minor medical conditions (e.g. seasonal allergies);
Females working on nightshifts;
Females on a strict diet or practicing extensively sports;
Females smoking more than 5 cigarettes/week;
Pregnant or lactating;
Females planning a pregnancy in the next 12 months;
Employee of the sponsor or CRO;
Investigator doubts truthfulness of self-reported health information;
Females otherwise apparently unsuited (lack of cognitive or verbal skills);
Females currently participating in another clinical study

Study & Design

• Study Type: interventional
• Study Design: Not specified