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Menstrual Cycle Symptoms and Female Health (CICLOS)

8 luglio 2026 aggiornato da: 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 The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

400

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
      • Madrid, Spagna
        • Reclutamento
        • Universidad Rey Juan Carlos
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Naturally menstruating females between 18 and 45 years

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Prevalence of symptoms related to menstrual cycle in naturally menstruating females
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP).
Lasso di tempo: 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).
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum estradiol concentrations
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Rey Juan Carlos

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 gennaio 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

11 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 41-01-ID25

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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