Trial document




drksid header

  DRKS00009005

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

L4-2015

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to evaluate the effects of a dietary supplement on symptoms of the premenstrual syndrome. The supplement used in this study has a patent in the USA for beneficial effects for alleviating symptoms associated with the premenstrual syndrome.
Participants are asked to fill out an online symptom diary daily for four cycles. There are 5 visits at the study site, where compliance is checked and a questionnaire has to be filled in. On the first and the last visit a blood sample is drawn for determination of several hormone levels. On 4 days of the first cycle and 4 days of the last cycle participants are asked to collect saliva samples at home for determination of cortisol levels. Study medication has to be taken three times a day for the last three cycles.
For this study 40 females, aged 18-45 years, will be recruited who have a gynecologist-confirmed premenstrual syndrome diagnosis. Subjects have to be otherwise healthy and are not allowed to take any medication or dietary supplements while participating (besides stable thyroid or blood pressure medication).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of this study is to evaluate the effect of PAS on PMS severity in women diagnosed with PMS. To achieve this, subjects with a PMS diagnosis will receive PAS or placebo and baseline and PMS symptom severity during treatment will be analyzed.
PMS patients have been shown to have lower cortisol concentrations premenstrual as compared to control subjects and as compared to postmenstrual, especially in the evenings (Girdler et al., 2001; Odber, Cawood, & Bancroft, 1998; Rabin et al., 1990). To test for effects of PAS on cortisol levels, subjects will collect saliva samples on eight days during the study. Samples will be collected during the first cycle (baseline) and during the last cycle (post-treatment) on two consecutive days in the follicular phase and two consecutive days in the luteal phase at awakening, 30 min, 45 min and 60 min after awakening (cortisol awakening response, CAR) and at 8pm.
Findings of our previous studies (in-house data) suggest, that PAS maintains serum corticosteroid binding globulin (CBG) levels in chronically stressed subjects. To confirm this finding, serum CBG levels and serum cortisol levels will be determined pre- and post-treatment.
Munday et al. (1981) found lower progesterone levels in women with PMS premenstrual compared to control subjects and higher estradiol levels in PMS patients over the last 4 days of the cycle compared to control subjects. Lombardi et al. (2004) found lower progesterone levels in women with PMS in both menstrual phases. To test if PAS has an effect on these hormones, serum progesterone and estradiol levels will be determined pre- and post-treatment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009005
  •   2015/08/05
  •   [---]*
  •   no
  •   Approved
  •   837.227.15 (9995), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Premenstrual Syndrome
  •   N94.3 -  Premenstrual tension syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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 phosphatidylserine, 100mg phosphatidic acid, 235mg other phospholipids & glycerides, 5mg silicon dioxide
  •   For 3 cycles: 4 placebo capsules per day, oral administration 3 times/day to the main meals (1-1-2)
    Ingredients per capsule: 435mg maze starch, 5mg silicon dioxide
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/07/24
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Lipogen Ltd.
    • Mr.  David  Rutenberg 
    • Yefe Nof St. 39
    • 34371  Haifa
    • Israel
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • daacro GmbH & Co. KG
    • Ms.  Dr.  Juliane  Hellhammer 
    • Max–Planck–Straße 22
    • 54296  Trier
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • daacro GmbH & Co. KG
    • Ms.  Dipl. Psych.  Nicole  Weber 
    • Max-Planck-Straße 22
    • 54296  Trier
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Lipogen Ltd.
    • Yefe Nof Str. 39
    • 34317  Haifa
    • Israel
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/05/29
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.