Menstrual Cycle Symptoms and Female Health

NCT07699224 | Recruiting

• 1 other identifier: 41-01-ID25
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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 The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as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

Conditions

Menstrual Cycle; Menstrual Distress (Dysmenorrhea); Premenstrual Syndrome; Abnormal Uterine Bleeding (AUB); Ovulation Disorder; Perceived Health Status

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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 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.

  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.

  once, at enrollment (baseline).

Secondary Outcomes (11)

• Serum estradiol concentrations

  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

  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)

  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

  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

  Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).

Study Arms (1)

Prevalence of symptoms related to menstrual cycle in naturally menstruating females

Other: Prevalence

Interventions

Prevalence OTHER

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.

Prevalence of symptoms related to menstrual cycle in naturally menstruating females

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Naturally menstruating females between 18 and 45 years

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea; Premenstrual Syndrome; Metrorrhagia

Interventions

Prevalence

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Morbidity; Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: July 13, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)