Premenstrual Syndrome N94.3
Conditions
Interventions
Group 1: For 3 cycles: 4 capsules Soy lecithin phosphatidylserine/phosphatidic acid complex (PAS) per day, oral administration 3 times/day to the main meals (1-1-2)
Ingredients per capsule: 100mg phos
Sponsors
Lipogen Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effects of PAS compared to placebo on severity of PMS symptomatology using daily online DRSP (Daily Record of Severity of Problems) tool. The DRSP was developed by Endicott et al. (2006) to aid in the diagnosis and evaluation of PMDD / PMS according to DSM-IV. It has been shown to be a reliable and valid measure of severity of problems concerning premenstrual symptoms. Several studies demonstrated a high test-retest reliability and internal consistency of summary scores in women who ranged from few/no premenstrual problems to those meeting the criteria for PMDD (Endicott et al., 2006). Summary scores were also reported to be sensitive to change and treatment differences.The DRSP questionnaire comprises 24 items to assess the severity of problems on a daily basis. Subjects rate their severity on a six-point rating scale ranging from 1 (not at all) to 6 (extreme). Psychological symptoms like depression, anxiousness, mood swings, irritability and difficulties in concentration but also physiological symptoms like breast tenderness, headache or weight gain are retrieved. The symptom diary has to be filled out every day in the evening to note the degree of the experienced problems. Within the study design the questionnaire will be completed every evening (5pm to 12am local time) online for 4 complete cycles in part A of the study (1 cycle baseline assessment, 3 cycles treatment assessment) and two additional complete cycles in part B of the study. Primary outcome of this study is the total score of this questionnaire acting as an objective indication of response to the therapy with PAS. The total score is calculated by summing up items 1a, 1b, 1c, 2, 3a, 3b, 4a, 4b, 5, 6, 7, 8a, 8b, 9a, 9b, 10a, 10b, 11a, 11b, 11c and 11d. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of PAS on depressive symptoms, physical symptoms, anger/irritability and within cycle increase in symptom severity using DRSP tool and on salivary cortisol. The DRSP questionnaire comprises 24 items to assess the severity of problems on a daily basis. Subjects rate their severity on a six-point rating scale ranging from 1 (not at all) to 6 (extreme). Psychological symptoms like depression, anxiousness, mood swings, irritability and difficulties in concentration but also physiological symptoms like breast tenderness, headache or weight gain are retrieved. The symptom diary has to be filled out every day in the evening to note the degree of the experienced problems. Within the study design the questionnaire will be completed every evening (5pm to 12am local time) online for 4 complete cycles in part A of the study (1 cycle baseline assessment, 3 cycles treatment assessment) and two additional complete cycles in part B of the study. The three subscales of the DRSP Depressive symptoms, Physical symptoms and Anger/irritability serve as secondary outcomes in this study. The Depressive symptoms subscore is calculated by summing up items 1a, 1b, 1c, 9a, 9b and 10a; the Physical symptoms subscore is calculated by summing up items 11a, 11b, 11c and 11d and the Anger/irritability subscore is calculated by summing up items 4a and 4b. In part A of this study salivary cortisol is assessed on days 8 and 9 of the individual menstrual cycle and days -4 and -3 of the individual menstruation at home (at awakening +0 min, +30 min, +45 min, +60 min and at 8pm) during the first and the last cycle. Saliva samples are collected by using Salivette® Cortisol (Sarstedt, Nuembrecht, Germany). | — |
Countries
Germany
Contacts
Public ContactNicole Weber
daacro GmbH & Co. KG
Outcome results
None listed