A Phase 3 interventional study of Placebo and Serelys PMS in Premenstrual Syndrome, sponsored by Jens Rikardt Andersen. Completed at 1 site in Denmark. Open to female participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by Jens Rikardt Andersen · Phase 3, Interventional, and Prevention
The objective of the present study is to better define and evaluate Serelys PMS in terms of the impact on the different premenstrual syndrome (PMS) symptoms , tolerance, satisfaction and overall quality of life of women with known discomforts during the premenstrual period. The data from this study will be compared to data when the two different ingredients are given as monotherapy.
More than every other women aged 15 to 50 years of age have premenstrual symptoms such as irritability, mood swings, fatigue, headaches, sleep disturbances, breast and abdominal pain, bloating, water retention and weight gain. Some signs continue during menstruation. These psychological and physical manifestations can make women vulnerable and have a negative impact on their professional, social and sexual life. Randomized, double-blind, placebo-controlled clinical studies demonstrated the beneficial effects of pollen extract in premenstrual discomfort. The premenstrual period is probably caused by a change in the normal amount of sex hormones which can induce disorders in the central neuroendocrine system and estrogens are reported to reduce PMS symptoms to some extend. Moreover, it is well established that serotonin may play a role in PMS, as some inhibitors of serotonin re-uptake (SSRI) have an impact on premenstrual disorders. However, side effects may occur even when using estrogens as well as SSRI. Recently the pollen extract formulation has been improved by adding a natural extract of saffron. This latter component is known for its beneficial action on maintaining comfort during the menstrual cycle of the woman and it especially supports mood changes, one of the mayor PMS symptoms. The effect of Safran was studied more specifically in a randomized controlled double-blind, placebo-controlled clinical trial in women with premenstrual discomfort. This study showed a progressive and significant improvement after the use of saffron. In an other study saffron was documented to improve mood in patients with milder depression.
In summary, the components of saffron helps to improve the well-being of women during the premenstrual and menstrual period and have a well documented impact on mood. The pollen based extracts have well documented impact on most of PMS symptoms but possibly lesser on mood changes, which is also one of the mayor symptoms of PMS. The mechanisms by which saffron and pollen based extraction works is expected to be different and an additive impact is expected. The investigation is initiated by the researchers who feel that in PMS an alternatives to SSRI and estrogen treatment is needed.
At least one of these criteria must be present in the premenstrual and menstrual period:
Exclusion Criteria:
2 capsules daily for 2 months containing inactive substances
Dietary Supplement: Placebo
2 capsules daily for 2 months containing pollen extract
Dietary Supplement: Serelys PMS
2 months treatment
2 months treatment
PMS symptoms evaluation - Premenstrual Tension
Premenstrual Tension Scale (PMTS) - Self-rating scale
Time frame: 2 months
PMS symptoms evaluation - Premenstrual Tension 2
Premenstrual Tension Scale (PMTS) - Observe Rating Scale
Time frame: 2 months
PMS symptoms evaluation - premenstrual discomfort
Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)
Time frame: 2 months
Side effect registration
Tolerance will be assessed through a scoring system
Time frame: 2 months
Satisfaction scored by the patients
Satisfaction and well-being will be assessed through a scoring system
Time frame: 2 months
Plan to share: No
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Jens Rikardt Andersen