Premenstrual SyndromePhase 3NCT03298607
The Impact of Serelys PMS on Symptoms of PMS
A Phase 3 study testing Serelys PMS in people with Premenstrual Syndrome, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Serelys PMS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Oct 2017to 1 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, 1958FC
About this study
Official title: The Impact of Sérélys PMS, a Herbal Remedy Based on Pollen Extraction and Saffron, on Symptoms of PMS: A Randomized, Double-blinded, Placebo Controlled Study
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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Placebo, Serelys PMS
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
2 months treatment
Serelys PMSDietary supplement
2 months treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 capsules daily for 2 months containing inactive substances Receives: Dietary Supplement: Placebo |
| Serelys PMS | Active comparator | 2 capsules daily for 2 months containing pollen extract Receives: Dietary Supplement: Serelys PMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PMS symptoms evaluation - Premenstrual Tension
Premenstrual Tension Scale (PMTS) - Self-rating scale
Measured: 2 months
PMS symptoms evaluation - Premenstrual Tension 2
Premenstrual Tension Scale (PMTS) - Observe Rating Scale
Measured: 2 months
PMS symptoms evaluation - premenstrual discomfort
Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)
Measured: 2 months
Secondary outcomes (2)
Side effect registration
Tolerance will be assessed through a scoring system
Measured: 2 months
Satisfaction scored by the patients
Satisfaction and well-being will be assessed through a scoring system
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start30 Oct 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 months treatment with (Food Supplement - Serelys PMS)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Serelys Pharma
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Kaj Winther Hansen, MD, Study chair, UCopenhagen, Department of Nutrition, Exercise and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298607
- Sponsor's protocol ID
- H-17014613
- Status last verified
- Oct 2018
- First submitted
- 7 Sep 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sérélys PMS, a Herbal Remedy Based on Pollen Extraction and Saffron, on Symptoms of PMS: A Randomized, Double-blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03298607
- Acronym / sponsor ID
- H-17014613
- Conditions
- Premenstrual Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Serelys Pharma
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 months treatment with (Food Supplement - Serelys PMS)
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules daily for 2 months containing inactive substances |
| Serelys PMS | Active comparator | Dietary Supplement: Serelys PMS2 capsules daily for 2 months containing pollen extract |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
- Have symptoms of dysphoria / premenstrual sadness at least during the previous 6 cycles.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 months treatment | Dietary supplement | Placebo |
| Serelys PMS2 months treatment | Dietary supplement | Serelys PMS |
Primary outcome
PMS symptoms evaluation - Premenstrual Tension
Time frame: 2 months
Premenstrual Tension Scale (PMTS) - Self-rating scale
PMS symptoms evaluation - Premenstrual Tension 2
Time frame: 2 months
Premenstrual Tension Scale (PMTS) - Observe Rating Scale
PMS symptoms evaluation - premenstrual discomfort
Time frame: 2 months
Evaluation of premenstrual discomfort by Visual Analog Scales (VAS)
2 secondary outcomes
Side effect registration
Time frame: 2 months
Satisfaction scored by the patients
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaj Winther Hansen, MD study chair
UCopenhagen, Department of Nutrition, Exercise and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serelys PMS in people with Premenstrual Syndrome, run by Jens Rikardt Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PMS symptoms evaluation - Premenstrual Tension (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.