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CompletedNCT03298607Updated Oct 15, 2018

The Impact of Serelys PMS on Symptoms of PMS

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

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Premenstrual Syndrome

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03

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least five inconveniences in the premenstrual period and which disappear quickly with the end of menstruation : Irritability, Tension, Fatigue, Dysphoria (sadness), Reduced motor coordination, Difficulty concentrating, Changes in libido, Changes in appetite.
  • these inconveniences disappear quickly with the end of menstruation
  • At least one of these criteria must be present in the premenstrual and menstrual period:

    1. Deterioration in relations with the family, at home, in school or at work
    2. Having thought to take painkillers for at least one menstrual cycle.
  • Have symptoms of dysphoria / premenstrual sadness at least during the previous 6 cycles.

Exclusion criteria

Exclusion Criteria:

  • Known allergy to any component of the product and known renal and hepatic impairment.
  • Existence of major evolving pathologies
  • Convulsions. Existence of psychiatric disorders, cravings
  • Suicidal thoughts
  • Taking medications that may interfere with PMS symptoms like eg estrogens.
  • Participation in another clinical study at the same time.
  • Pregnancy and / or lactation;
  • Difficulties to collaborate and difficulties to understand and complete the questionnaires.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    2 capsules daily for 2 months containing inactive substances

    Dietary Supplement: Placebo

  • Active comparator
    Serelys PMS

    2 capsules daily for 2 months containing pollen extract

    Dietary Supplement: Serelys PMS

Interventions

  • Dietary supplementPlacebo

    2 months treatment

  • Dietary supplementSerelys PMS

    2 months treatment

05

What researchers measure

Primary outcomes

  1. PMS symptoms evaluation - Premenstrual Tension

    Premenstrual Tension Scale (PMTS) - Self-rating scale

    Time frame: 2 months

  2. PMS symptoms evaluation - Premenstrual Tension 2

    Premenstrual Tension Scale (PMTS) - Observe Rating Scale

    Time frame: 2 months

  3. PMS symptoms evaluation - premenstrual discomfort

    Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)

    Time frame: 2 months

Secondary outcomes

  1. Side effect registration

    Tolerance will be assessed through a scoring system

    Time frame: 2 months

  2. Satisfaction scored by the patients

    Satisfaction and well-being will be assessed through a scoring system

    Time frame: 2 months

06

Study locations

1 site
  • Department of Nutrition, Exercise and Sports, University of Copenhagen
    Copenhagen, 1958FC, Denmark
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03298607
Lead sponsor
Jens Rikardt Andersen
Collaborators
Serelys Pharma
Responsible party
Jens Rikardt Andersen (Adj Professor, Department of Nutrition, Exercise and Sports, University of Copenhagen) — Sponsor-investigator
First posted
Oct 2, 2017
Start date
Oct 30, 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Oct 15, 2018

Study contacts

Kaj Winther Hansen, MD
study chair · UCopenhagen, Department of Nutrition, Exercise and Sport

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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