The Impact of Serelys PMS on Symptoms of PMS

NCT03298607 | Completed Phase 3

• 1 other identifier: H-17014613
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (3)

• PMS symptoms evaluation - Premenstrual Tension

  Premenstrual Tension Scale (PMTS) - Self-rating scale

  2 months

• PMS symptoms evaluation - Premenstrual Tension 2

  Premenstrual Tension Scale (PMTS) - Observe Rating Scale

  2 months

• PMS symptoms evaluation - premenstrual discomfort

  Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)

  2 months

Secondary Outcomes (2)

• Side effect registration

  2 months

• Satisfaction scored by the patients

  2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 capsules daily for 2 months containing inactive substances

Dietary Supplement: Placebo

Serelys PMS

ACTIVE COMPARATOR

2 capsules daily for 2 months containing pollen extract

Dietary Supplement: Serelys PMS

Interventions

Placebo DIETARY_SUPPLEMENT

2 months treatment

Placebo

Serelys PMS DIETARY_SUPPLEMENT

2 months treatment

Serelys PMS

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jens Rikardt Andersen: lead
• Serelys Pharma: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, 1958FC, Denmark

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaj Winther Hansen, MD

  UCopenhagen, Department of Nutrition, Exercise and Sport

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adj Professor, Department of Nutrition, Exercise and Sports

Model Details: 2 months treatment with (Food Supplement - Serelys PMS)

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: October 2, 2017
• Study Start: October 30, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)