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Menstrual Cycle Symptoms and Female Health (CICLOS)

8 juli 2026 bijgewerkt door: Nuria Romero Parra, Universidad Rey Juan Carlos

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 The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as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.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

400

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Spanje
      • Madrid, Spanje
        • Werving
        • Universidad Rey Juan Carlos
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Naturally menstruating females between 18 and 45 years

Beschrijving

Inclusion Criteria:

  • Females
  • Between 18 and 45 years
  • Naturally menstruating.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Hormonal contraceptive methods during the 6 months before the study.
  • hysterectomy or ooforectomy.
  • Smoking.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Prevalence of symptoms related to menstrual cycle in naturally menstruating females
Ander: Prevalence
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP).
Tijdsspanne: 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.
Daily through study completion, an average of 3 months.
Menstrual cycle-related distress using the Menstrual Distress Questionnaire (MEDI-Q).
Tijdsspanne: 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.
once, at enrollment (baseline).
Dysmenorrhea using the Disnenorrhea Symptom Interference Scale (DSI)
Tijdsspanne: 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.
Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
SAMANTA Bleeding Questionnaire.
Tijdsspanne: 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.
once, at enrollment (baseline).
Luteinizing hormone (LH) surge prior ovulation
Tijdsspanne: 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.
Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
Ovulation
Tijdsspanne: 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).
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
Tijdsspanne: 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.
once, at enrollment (baseline).
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS)
Tijdsspanne: 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.
once, at enrollment (baseline).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Serum estradiol concentrations
Tijdsspanne: 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 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).
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
Tijdsspanne: 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 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).
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)
Tijdsspanne: 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 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.
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
Tijdsspanne: 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 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).
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
Tijdsspanne: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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.
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting glucose concentrations
Tijdsspanne: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting glucose concentrations to assess glycemic health status will be assessed. Unit of measure: mg/dL.
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting insulin concentrations
Tijdsspanne: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Fasting insulin concentrations to assess glycemic health status will be assessed. Unit of measure: µIU/mL.
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Glycated hemoglobin (HbA1c) concentrations.
Tijdsspanne: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Glycated hemoglobin (HbA1c) concentrations from venus samples to assess average glycemic status will be obtained. Unit of measure: %
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
Serum high-sensitivity C-reactive protein (hs-CRP) concentrations
Tijdsspanne: Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
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.
Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
Serum homocysteine concentrations
Tijdsspanne: Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
Serum homocysteine will be assessed from venous blood samples as a biomarker associated with systemic inflammation and cardiometabolic health. Unit of measure: µmol/L.
Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
Bone mineral density assessed using dual-energy X-ray absorptiometry (DXA)
Tijdsspanne: Baseline
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.
Baseline

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Sponsor

Universidad Rey Juan Carlos

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 januari 2026

Primaire voltooiing (Geschat)

1 oktober 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

11 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 41-01-ID25

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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