Menstrual ProblemNCT05442541
Menstrual Wellbeing in Woman Living in Turkey; an Epidemiological Study
An observational study of Menstrual Problem and Quality of Life, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Women with endometriosis in our country and around the world face various difficulties during their menstrual periods in reproductive age. While some of these difficulties are caused by the environment, some of them are due to the insufficient development of personal consciousness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Problem, Quality of Life
- What is being tested?
- not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,829 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Feb 2022
- How long will I take part?
- 1 Month
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Menstruating women of reproductive age between the ages of 18- 45 will be included in this study.
Who may be able to join
- Menstruating women of reproductive age between the ages of 18- 45 will be included in this study.
Who cannot join
- Women with a history of hematological disease, cardiovascular disease, malignancy, advanced renal failure, active infection, diabetes mellitus, and pregnant women will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lutfi Kirdar Research and Training Hospital
Istanbul
About this study
Official title: Üreme çağındaki kadınlarda menstrüel Iyilik Halinin değerlendirilmesi Saha Anket çalışması/Evaluation of Menstrual Well-being in Women of Reproductive Age, Field Survey Study
Women with endometriosis in our country and around the world face various difficulties during their menstrual periods in reproductive age. While some of these difficulties are caused by the environment, some of them are due to the insufficient development of personal consciousness. In our study, we aim to reveal the perspective of individuals and society on the menstrual period. Our primary aim in our study is to understand what kind of problems are experienced in different regions of our country during the menstrual period for women and how they are spent. Secondly, the effect of this period on women's quality of life will be examined.
Read the detailed description
Our research will be conducted between January 1, 2022, and February 1, 2022, in 7 different regions of our country, by asking questions to women of reproductive age from different groups. Each participant will be asked to answer the survey questions and the results will be analyzed. The survey will be done face to face. The questionnaire contains questions about women's socio-demographic data, their perspectives on their menstrual period, their information about endometriosis, and their perspectives on pads and birth control pills. Menstruating women of reproductive age between the ages of 18- 45 will be included in this study. As a result of the study, the problems experienced by women of reproductive age in different regions will be evaluated.
- Conditions
- Menstrual Problem, Quality of Life
- Being tested
- not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)
- Keywords
- menstrual wellbeing, reproductive age, oral contraceptive, endometriosis
- Medical subject headings
- Menstruation Disturbances, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)Behavioural
This is a prospective cross-sectional analytical study conducted through a questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disparities in menstrual hygiene and well-being between 7 regions of Turkey in women of reproductive age with a questionnaire
In this study, the effect of the menstrual period on the quality of life of 1829 women living in seven different geographical regions of our country will be examined through a questionnaire. The goal of this study is to evaluate the menstrual well-being of women living in different regions of our country.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual ProblemStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,829 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Turkish Endometriosis and Adenomyosis Society, IPSOS
- Responsible party
- Principal investigator, Elif Cansu Gundogdu, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Ahmet Kale, Prof.Dr., Study director, Kartal Dr. Lutfi Kirdar Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442541
- Sponsor's protocol ID
- 2021/514/216/15
- Status last verified
- Jun 2022
- First submitted
- 12 Jan 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Üreme çağındaki kadınlarda menstrüel Iyilik Halinin değerlendirilmesi Saha Anket çalışması/Evaluation of Menstrual Well-being in Women of Reproductive Age, Field Survey Study
- ClinicalTrials.gov ID
- NCT05442541
- Acronym / sponsor ID
- 2021/514/216/15
- Conditions
- Menstrual Problem, Quality of Life
- Keywords
- menstrual wellbeing, reproductive age, oral contraceptive, endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,829 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Collaborators
- Turkish Endometriosis and Adenomyosis Society, IPSOS
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 Jul 2022 (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.
Women with endometriosis in our country and around the world face various difficulties during their menstrual periods in reproductive age. While some of these difficulties are caused by the environment, some of them are due to the insufficient development of personal consciousness. In our study, we aim to reveal the perspective of individuals and society on the menstrual period. Our primary aim in our study is to understand what kind of problems are experienced in different regions of our country during the menstrual period for women and how they are spent. Secondly, the effect of this period on women's quality of life will be examined.
Detailed description
Our research will be conducted between January 1, 2022, and February 1, 2022, in 7 different regions of our country, by asking questions to women of reproductive age from different groups. Each participant will be asked to answer the survey questions and the results will be analyzed. The survey will be done face to face. The questionnaire contains questions about women's socio-demographic data, their perspectives on their menstrual period, their information about endometriosis, and their perspectives on pads and birth control pills. Menstruating women of reproductive age between the ages of 18- 45 will be included in this study. As a result of the study, the problems experienced by women of reproductive age in different regions will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Menstruating women of reproductive age between the ages of 18- 45 will be included in this study.
Key inclusion criteria (1 listed)
- Menstruating women of reproductive age between the ages of 18- 45 will be included in this study.
Key exclusion criteria (1 listed)
- Women with a history of hematological disease, cardiovascular disease, malignancy, advanced renal failure, active infection, diabetes mellitus, and pregnant women will not be included 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 |
|---|---|---|
| not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)This is a prospective cross-sectional analytical study conducted through a questionnaire. | Behavioural | – |
Primary outcome
Disparities in menstrual hygiene and well-being between 7 regions of Turkey in women of reproductive age with a questionnaire
Time frame: 1 month
In this study, the effect of the menstrual period on the quality of life of 1829 women living in seven different geographical regions of our country will be examined through a questionnaire. The goal of this study is to evaluate the menstrual well-being of women living in different regions of our country.
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 5 Jul 2022.
- Individual participant dataSharing planned: Undecided. not decided yet.
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.
Ahmet Kale, Prof.Dr. study director
Kartal Dr. Lutfi Kirdar Research and Training Hospital
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 Menstrual Problem and Quality of Life, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 5 Jul 2022. 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 Turkey (Türkiye). 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?
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?
Disparities in menstrual hygiene and well-being between 7 regions of Turkey in women of reproductive age with a questionnaire (time frame: 1 month). 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 5 Jul 2022.