The Impact of Serelys PMS on Symptoms of PMS

NCT ID: NCT03298607

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2018-06-01

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.

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.

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

2 capsules daily for 2 months containing inactive substances

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

2 months treatment

Serelys PMS

2 capsules daily for 2 months containing pollen extract

Group Type: ACTIVE_COMPARATOR

Serelys PMS

Intervention Type: DIETARY_SUPPLEMENT

2 months treatment

Interventions

Placebo

2 months treatment

Intervention Type: DIETARY_SUPPLEMENT

Serelys PMS

2 months treatment

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Serelys Pharma

UNKNOWN

Sponsor Role: collaborator

Jens Rikardt Andersen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Adj Professor, Department of Nutrition, Exercise and Sports

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kaj Winther Hansen, MD

Role: STUDY_CHAIR

UCopenhagen, Department of Nutrition, Exercise and Sport

Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-17014613

Identifier Type: -

Identifier Source: org_study_id