Menstrual CycleCICLOSNCT07699224
Menstrual Cycle Symptoms and Female Health
An observational study of Menstrual Cycle and Menstrual Distress (Dysmenorrhea), run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The complexity inherent to the hormonal fluctuations associated with the female menstrual cycle (MC) has contributed, from a methodological perspective in research, to the neglect of women's physiological characteristics and to the silencing and normalization of symptoms linked to different life stages and hormonal… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Cycle, Menstrual Distress (Dysmenorrhea), Premenstrual Syndrome
- What is being tested?
- Prevalence
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2026to Dec 2026
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Study population: Naturally menstruating females between 18 and 45 years
Who may be able to join
- Females
- Between 18 and 45 years
- Naturally menstruating.
Who cannot join
- Pregnant or breastfeeding.
- Hormonal contraceptive methods during the 6 months before the study.
- hysterectomy or ooforectomy.
- Smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Madrid
Nuria Romero-Parra, Doctor, +34 617150826, nuria.romero@urjc.es
About this study
Official title: Prevalence of Subclinical Ovulatory Disturbances and Symptoms During the Menstrual Cycle and Their Relationship With Physical and Mental Health in Spanish Women of Reproductive Age (Prevalencia de Alteraciones Ovulatorias subclínicas y síntomas Durante el CICLO Menstrual y su relación Con la Salud física y Mental en Mujeres españolas en Edad Reproductiva).
The complexity inherent to the hormonal fluctuations associated with the female menstrual cycle (MC) has contributed, from a methodological perspective in research, to the neglect of women's physiological characteristics and to the silencing and normalization of symptoms linked to different life stages and hormonal environments. The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as intermenstrual discomfort. These symptoms not only significantly impair daily activities but, due to their normalization, often lead to the underdiagnosis of other gynecological conditions.
Subclinical ovulatory disturbances-characterized by the suppression of ovarian hormones as an adaptive defense mechanism against various environmental stressors-are also frequently underdiagnosed. These disturbances typically do not affect MC length, making them difficult to detect, and although the process is reversible, it may initiate irreversible consequences for certain tissues, such as bone mass loss. However, neither women nor their educational, occupational, or healthcare environments appear to have the resources and/or knowledge required to adequately address these issues.
Read more
All of this may compromise women's rights to adequate sexual and reproductive health and to a dignified quality of life, as recognized under the second line of Axis 4, "Effective Rights for All Women," of the Strategic Plan for Effective Equality between Women and Men 2022-2025. Therefore, the aims of this multicenter project-carried out by a multidisciplinary research team from seven Spanish universities and three international institutions-are to describe the prevalence of symptoms and alterations related to the MC in women of reproductive age and to identify their associations with physical and mental health.
To accomplish this, an observational study will be conducted in a large sample of women of reproductive age, including multiple symptom and perceived-health questionnaires and ovulation monitoring. In addition, in a subsample of participants, bone mineral density will be assessed, blood levels of sex hormones will be monitored, and an innovative analysis of health biomarkers (glycemic and lipid profile, and inflammation) from menstrual blood will be included. This will be complemented by a qualitative study of experiences related to MC-associated symptoms and alterations, using in-depth interviews and thematic content analysis.
The findings of this project are expected to support various dissemination and educational actions, justify the design of more inclusive educational and healthcare policies, and enhance the understanding of women's needs, ultimately contributing to improved symptom management and quality of life.
- Conditions
- Menstrual Cycle, Menstrual Distress (Dysmenorrhea), Premenstrual Syndrome, Abnormal Uterine Bleeding (AUB), Ovulation Disorder, Perceived Health Status
- Being tested
- Prevalence
- Medical subject headings
- Dysmenorrhea, Premenstrual Syndrome, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevalenceOther
Fulfilling the following questionnaires: Daily Record of Severity of Problems (DRSP), Menstrual Distress Questionnaire (MEDI-Q), SAMANTA Bleeding Questionnaire, Dismenorrhea symptom Interference (DSI), EQ-5D-5L questionnaire, quality of life and mental health questionnaires, urine ovulation tests.
| Study group | Role | What they receive |
|---|---|---|
| Prevalence of symptoms related to menstrual cycle in naturally menstruating females | Not described Receives: Other: Prevalence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP).
The DRSP is a prospective and validated questionnaire to assess the presence and severity of premenstrual symptoms. Participants rate 3 dimensions (depressive, physical and irritability) of symptoms on a 6-point Likert scale ranging from 1 (not at all) to 6 (extreme). The total symptom score is calculated by summing responses across symptom items, with higher scores indicating greater symptom severity and functional impairment.
Measured: Daily through study completion, an average of 3 months.
Menstrual cycle-related distress using the Menstrual Distress Questionnaire (MEDI-Q).
The MEDI-Q is a 25-item instrument designed to assess menstruation-related distress. It evaluates symptoms including pain, discomfort, emotional and cognitive changes, gastrointestinal symptoms, and alterations in physiological functioning. The questionnaire provides a Total Score reflecting overall menstrual distress, as well as three subscales: Menstrual Symptoms (MS), Menstrual Symptoms Distress (MSD), and Menstrual Specificity Index (MESI). Higher scores indicate greater menstrual-related distress. A Total Score ≥20 has been proposed as indicative of clinically distressful menstruation.
Measured: once, at enrollment (baseline).
Dysmenorrhea using the Disnenorrhea Symptom Interference Scale (DSI)
The DSI evaluates the extent to which menstrual pain interferes with daily activities, physical functioning, emotional well-being, and social participation on a 6-point Likert scale ranging from 1 (not at all) to 6 (extreme). The total symptom score is calculated by summing responses across symptom items. Higher scores indicate greater pain-related interference.
Measured: Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
SAMANTA Bleeding Questionnaire.
The SAMANTA Questionnaire is a 6-item screening tool designed to identify heavy menstrual bleeding (HMB) that interferes with quality of life. Items are answered using a dichotomous yes/no format and generate a total score ranging from 0 to 10 points. Higher scores indicate greater likelihood of heavy menstrual bleeding affecting daily life. A total score of 3 or higher suggests clinically relevant heavy menstrual bleeding.
Measured: once, at enrollment (baseline).
Luteinizing hormone (LH) surge prior ovulation
Urinary LH test to detect the LH hormone surge occurring 12-36 h prior ovulation.
Measured: Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
Ovulation
Ovulation will be confirmed by measurement of mid-luteal serum progesterone concentration. Ovulation is considered confirmed when progesterone concentrations reach or exceed 16 nmol/L (4.61 ng/mL).
Measured: measured once, in days 6 to 9 after a positive urinary luteinizing hormone (LH) test during each monitored menstrual cycle.
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Value
The EQ-5D-5L Index Value is a standardized measure of health-related quality of life derived from five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a single index value, with higher values indicating better perceived health status.
Measured: once, at enrollment (baseline).
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS)
The EQ Visual Analogue Scale (EQ-VAS) is a self-rated measure of overall health ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better perceived health status.
Measured: once, at enrollment (baseline).
Secondary outcomes (11)
Serum estradiol concentrations
Serum concentrations of estradiol from venous blood samples will be measured to characterize hormonal fluctuations across the menstrual cycle. Unit of measure: pg/mL (or pmol/L, depending on laboratory equipment).
Measured: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Serum progesterone concentrations
Serum concentrations of progesterone from venous blood samples will be measured to characterize hormonal fluctuations across the menstrual cycle. Unit of measure: Unit of measure: ng/mL (or nmol/L).
Measured: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Serum gonadotropin concentrations: luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
Serum concentrations of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), will be measured to characterize hormonal fluctuations across the menstrual cycle. Unit of measure IU/L.
Measured: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Serum testosterone concentrations
Serum concentrations of testosterone from venous blood samples will be measured to characterize hormonal fluctuations across the menstrual cycle. Unit of measure: Unit of measure: ng/mL (or nmol/L).
Measured: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Lipid profile biomarkers assessed from venous blood samples
Lipid health status will be assessed through measurement of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride concentrations obtained from venous blood samples. All measurements' units are mg/dL.
Measured: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting glucose concentrations
Fasting glucose concentrations to assess glycemic health status will be assessed. Unit of measure: mg/dL.
Measured: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting insulin concentrations
Fasting insulin concentrations to assess glycemic health status will be assessed. Unit of measure: µIU/mL.
Measured: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Glycated hemoglobin (HbA1c) concentrations.
Glycated hemoglobin (HbA1c) concentrations from venus samples to assess average glycemic status will be obtained. Unit of measure: %
Measured: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Serum high-sensitivity C-reactive protein (hs-CRP) concentrations
High-sensitivity C-reactive protein (hs-CRP) will be assessed from venous blood samples tas a marker of systemic inflammation. Unit of measure: mg/L.
Measured: Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
Serum homocysteine concentrations
Serum homocysteine will be assessed from venous blood samples as a biomarker associated with systemic inflammation and cardiometabolic health. Unit of measure: µmol/L.
Measured: Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
Bone mineral density assessed using dual-energy X-ray absorptiometry (DXA)
Bone mineral density (BMD) will be assessed using dual-energy X-ray absorptiometry (DXA). BMD values will be used to evaluate bone health and to explore associations with menstrual cycle characteristics, ovulatory status, and sex hormone concentrations.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start21 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuria Romero Parra, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699224
- Sponsor's protocol ID
- 41-01-ID25
- Acronym
- CICLOS
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2026
- Last updated
- 13 Jul 2026
- Results posted
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subclinical Ovulatory Disturbances and Symptoms During the Menstrual Cycle and Their Relationship With Physical and Mental Health in Spanish Women of Reproductive Age (Prevalencia de Alteraciones Ovulatorias subclínicas y síntomas Durante el CICLO Menstrual y su relación Con la Salud física y Mental en Mujeres españolas en Edad Reproductiva).
- ClinicalTrials.gov ID
- NCT07699224
- Acronym / sponsor ID
- CICLOS / 41-01-ID25
- Conditions
- Menstrual Cycle, Menstrual Distress (Dysmenorrhea), Premenstrual Syndrome, Abnormal Uterine Bleeding (AUB), Ovulation Disorder, Perceived Health Status
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jul 2026 (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 complexity inherent to the hormonal fluctuations associated with the female menstrual cycle (MC) has contributed, from a methodological perspective in research, to the neglect of women's physiological characteristics and to the silencing and normalization of symptoms linked to different life stages and hormonal environments. The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as intermenstrual discomfort. These symptoms not only significantly impair daily activities but, due to their normalization, often lead to the underdiagnosis of other gynecological conditions.
Subclinical ovulatory disturbances-characterized by the suppression of ovarian hormones as an adaptive defense mechanism against various environmental stressors-are also frequently underdiagnosed. These disturbances typically do not affect MC length, making them difficult to detect, and although the process is reversible, it may initiate irreversible consequences for certain tissues, such as bone mass loss. However, neither women nor their educational, occupational, or healthcare environments appear to have the resources and/or knowledge required to adequately address these issues.
All of this may compromise women's rights to adequate sexual and reproductive health and to a dignified quality of life, as recognized under the second line of Axis 4, "Effective Rights for All Women," of the Strategic Plan for Effective Equality between Women and Men 2022-2025. Therefore, the aims of this multicenter project-carried out by a multidisciplinary research team from seven Spanish universities and three international institutions-are to describe the prevalence of symptoms and alterations related to the MC in women of reproductive age and to identify their associations with physical and mental health.
To accomplish this, an observational study will be conducted in a large sample of women of reproductive age, including multiple symptom and perceived-health questionnaires and ovulation monitoring. In addition, in a subsample of participants, bone mineral density will be assessed, blood levels of sex hormones will be monitored, and an innovative analysis of health biomarkers (glycemic and lipid profile, and inflammation) from menstrual blood will be included. This will be complemented by a qualitative study of experiences related to MC-associated symptoms and alterations, using in-depth interviews and thematic content analysis.
The findings of this project are expected to support various dissemination and educational actions, justify the design of more inclusive educational and healthcare policies, and enhance the understanding of women's needs, ultimately contributing to improved symptom management and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevalence of symptoms related to menstrual cycle in naturally menstruating females | – | Other: Prevalence |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Naturally menstruating females between 18 and 45 years
Key inclusion criteria (3 listed)
- Females
- Between 18 and 45 years
- Naturally menstruating.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding.
- Hormonal contraceptive methods during the 6 months before the study.
- hysterectomy or ooforectomy.
- Smoking.
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 |
|---|---|---|
| PrevalenceFulfilling the following questionnaires: Daily Record of Severity of Problems (DRSP), Menstrual Distress Questionnaire (MEDI-Q), SAMANTA Bleeding Questionnaire, Dismenorrhea symptom Interference (DSI), EQ-5D-5L questionnaire, quality of life and mental health questionnaires, urine ovulation tests. | Other | Prevalence of symptoms related to menstrual cycle in naturally menstruating females |
Primary outcome
Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP).
Time frame: Daily through study completion, an average of 3 months.
The DRSP is a prospective and validated questionnaire to assess the presence and severity of premenstrual symptoms. Participants rate 3 dimensions (depressive, physical and irritability) of symptoms on a 6-point Likert scale ranging from 1 (not at all) to 6 (extreme). The total symptom score is calculated by summing responses across symptom items, with higher scores indicating greater symptom severity and functional impairment.
Menstrual cycle-related distress using the Menstrual Distress Questionnaire (MEDI-Q).
Time frame: once, at enrollment (baseline).
The MEDI-Q is a 25-item instrument designed to assess menstruation-related distress. It evaluates symptoms including pain, discomfort, emotional and cognitive changes, gastrointestinal symptoms, and alterations in physiological functioning. The questionnaire provides a Total Score reflecting overall menstrual distress, as well as three subscales: Menstrual Symptoms (MS), Menstrual Symptoms Distress (MSD), and Menstrual Specificity Index (MESI). Higher scores indicate greater menstrual-related distress. A Total Score ≥20 has been proposed as indicative of clinically distressful menstruation.
Dysmenorrhea using the Disnenorrhea Symptom Interference Scale (DSI)
Time frame: Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
The DSI evaluates the extent to which menstrual pain interferes with daily activities, physical functioning, emotional well-being, and social participation on a 6-point Likert scale ranging from 1 (not at all) to 6 (extreme). The total symptom score is calculated by summing responses across symptom items. Higher scores indicate greater pain-related interference.
SAMANTA Bleeding Questionnaire.
Time frame: once, at enrollment (baseline).
The SAMANTA Questionnaire is a 6-item screening tool designed to identify heavy menstrual bleeding (HMB) that interferes with quality of life. Items are answered using a dichotomous yes/no format and generate a total score ranging from 0 to 10 points. Higher scores indicate greater likelihood of heavy menstrual bleeding affecting daily life. A total score of 3 or higher suggests clinically relevant heavy menstrual bleeding.
Luteinizing hormone (LH) surge prior ovulation
Time frame: Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
Urinary LH test to detect the LH hormone surge occurring 12-36 h prior ovulation.
Ovulation
Time frame: measured once, in days 6 to 9 after a positive urinary luteinizing hormone (LH) test during each monitored menstrual cycle.
Ovulation will be confirmed by measurement of mid-luteal serum progesterone concentration. Ovulation is considered confirmed when progesterone concentrations reach or exceed 16 nmol/L (4.61 ng/mL).
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Value
Time frame: once, at enrollment (baseline).
The EQ-5D-5L Index Value is a standardized measure of health-related quality of life derived from five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a single index value, with higher values indicating better perceived health status.
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: once, at enrollment (baseline).
The EQ Visual Analogue Scale (EQ-VAS) is a self-rated measure of overall health ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better perceived health status.
11 secondary outcomes
Serum estradiol concentrations
Time frame: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Serum progesterone concentrations
Time frame: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Serum gonadotropin concentrations: luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
Time frame: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Serum testosterone concentrations
Time frame: At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
Lipid profile biomarkers assessed from venous blood samples
Time frame: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting glucose concentrations
Time frame: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting insulin concentrations
Time frame: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Glycated hemoglobin (HbA1c) concentrations.
Time frame: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Serum high-sensitivity C-reactive protein (hs-CRP) concentrations
Time frame: Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
Serum homocysteine concentrations
Time frame: Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
Bone mineral density assessed using dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
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 Cycle and Menstrual Distress (Dysmenorrhea), run by Universidad Rey Juan Carlos at 1 site in Spain.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP). (time frame: Daily through study completion, an average of 3 months.). The study lists 8 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 13 Jul 2026.