Status:
COMPLETED
The Impact of Serelys PMS on Symptoms of PMS
Lead Sponsor:
Jens Rikardt Andersen
Collaborating Sponsors:
Serelys Pharma
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
21-50 years
Phase:
PHASE3
Brief 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 quali...
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 ...
Eligibility Criteria
Inclusion
- 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:
- Deterioration in relations with the family, at home, in school or at work
- 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
- 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.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03298607
Start Date
October 30 2017
End Date
June 1 2018
Last Update
October 15 2018
Active Locations (1)
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1
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Denmark, 1958FC