Premenstrual SyndromeSd-PremensNCT06117215
Prevalence of Premenstrual Syndrome in Women of Reproductive Age
An observational study of Premenstrual Syndrome, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial summary
The menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome. Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Data collection
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 1 May 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women of chilbearing age
Who may be able to join
- women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal
- Over 18 years of age
- Agreeing to participate in the study
Who cannot join
- Menopause
- Having had a hysterectomy
- With primary amenorrhea
- Protected by law
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome.
Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. This definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women.
Read more
The impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. Therefore, few women report the existence of these disorders to healthcare professionals. As the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed.
This pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome.
Read the detailed description
The main aim is to describe the prevalence of premenstrual syndrome among women of reproductive age.
- Conditions
- Premenstrual Syndrome
- Being tested
- Data collection
- Keywords
- Premenstrual syndrome, women reproductive age, prevalence
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
data collection
| Study group | Role | What they receive |
|---|---|---|
| women of reproductive age | women of reproductive age Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
premenstrual syndrome
Prevalence of premenstrual syndrome defined as a set of physical, psychic and behavioral symptoms, appearing in the luteal phase of the menstrual cycle (that is, in the days before menstruation) and yielding with them, conditioned by a sufficient severity to alter the overall functioning and quality of life of women and must be present over at least 2 consecutive cycles.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristner Pauline, Dr, Principal investigator, CH Épernay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117215
- Sponsor's protocol ID
- 2023_RIPH_014_Sd-Premens
- Acronym
- Sd-Premens
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Premenstrual Syndrome in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT06117215
- Acronym / sponsor ID
- Sd-Premens / 2023_RIPH_014_Sd-Premens
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual syndrome, women reproductive age, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Nov 2023 (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 menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome.
Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. This definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women.
The impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. Therefore, few women report the existence of these disorders to healthcare professionals. As the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed.
This pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome.
Detailed description
The main aim is to describe the prevalence of premenstrual syndrome among women of reproductive age.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women of reproductive age | – | Other: Data collectionwomen of reproductive age |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women of chilbearing age
Key inclusion criteria (3 listed)
- women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal
- Over 18 years of age
- Agreeing to participate in the study
Key exclusion criteria (5 listed)
- Menopause
- Having had a hysterectomy
- With primary amenorrhea
- Protected by law
- Refusing to participate in the study
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 |
|---|---|---|
| Data collectiondata collection | Other | women of reproductive age |
Primary outcome
premenstrual syndrome
Time frame: Day 0
Prevalence of premenstrual syndrome defined as a set of physical, psychic and behavioral symptoms, appearing in the luteal phase of the menstrual cycle (that is, in the days before menstruation) and yielding with them, conditioned by a sufficient severity to alter the overall functioning and quality of life of women and must be present over at least 2 consecutive cycles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Kristner Pauline, Dr principal investigator
CH Épernay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome, run by Université de Reims Champagne-Ardenne at 1 site in France.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie (0326913665 ext. +33, coralie.barbe@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
premenstrual syndrome (time frame: Day 0). 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 3 Nov 2023.