FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women (FLOW)

November 2, 2026 updated by: Hospices Civils de Lyon

Influence of the Menstrual Cycle on Alcohol Consumption, Anxiety, Physical Activity and Sleep in Women: A Prospective Longitudinal Observational Cohort Study (FLOW)

The FLOW study aims to assess the association between menstrual cycle phases and alcohol consumption in women from the general population. Hormonal fluctuations throughout the menstrual cycle may influence alcohol use behaviors, anxiety levels, physical activity, and sleep quality. Participants will be followed prospectively for three consecutive menstrual cycles through monthly questionnaires assessing alcohol consumption, anxiety, physical activity, and sleep.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Alcohol consumption among women has increased in recent years and represents a major public health concern. Emerging evidence suggests that ovarian hormones may influence vulnerability to substance use and addictive behaviors. The menstrual cycle provides a physiological model to investigate the effects of hormonal fluctuations on alcohol consumption patterns.

FLOW is a prospective, longitudinal, observational cohort study designed to evaluate the relationship between menstrual cycle phases and alcohol consumption in women with regular menstrual cycles. Participants will complete online self-administered questionnaires at baseline (Month 1) and during two subsequent monthly follow-up assessments (Month 2 and Month 3).

Data collected include menstrual cycle characteristics, alcohol use assessed using the Alcohol Timeline Followback (A-TLFB), anxiety symptoms measured by the Generalized Anxiety Disorder-7 scale (GAD-7), physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), and sleep quality assessed using the Mini Sleep Questionnaire (MSQ).

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Valentine LHORTOLAT, Midwife
Phone Number: +33 4 78 86 41 00
Email: valentine.lhortolat@chu-lyon.fr

Study Contact Backup

Name: Benjamin ROLLAND, MD
Email: Benjamin.rolland@chu-lyon.fr

Study Locations

France
- - Pierre-Bénite, France, 69495
    - Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
    - Contact:
      
      Valentine LHORTOLAT, Midwife
      
      Phone Number: +33 4 78 86 41 00
      
      Email: valentine.lhortolat@chu-lyon.fr
    - Principal Investigator:
      
      Valentine LHORTOLAT, Midwife

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women from the general population with regular menstrual cycles.

Description

Inclusion Criteria:

Female
Age between 18 and 45 years
Regular menstrual cycle lasting between 21 and 37 days
Able to complete online questionnaires
Provides informed consent

Exclusion Criteria:

Postmenopausal women
Use of medications interfering with menstrual cycle physiology, other than contraception
Initiation of hormonal contraception within the previous 3 months
Pregnant women
Breastfeeding women
Pregnancy planned within the next 3 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of an alcohol consumption day Time Frame: Up to 3 months	Assessment of whether alcohol was consumed (Yes/No), measured using the Alcohol Timeline Followback (A-TLFB) over the previous 7 days, across three menstrual cycles	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of binge drinking days Time Frame: Up to 3 months	Number of days with excessive alcohol consumption during the previous 7 days, assessed using A-TLFB. Excessive alcohol consumption is defined as at least six standard drinks consumed on a given day.	Up to 3 months
Association between alcohol consumption and anxiety levels over time Time Frame: Up to 3 months	Correlation between average alcohol consumption and anxiety levels assessed using GAD-7 throughout the menstrual cycle.	Up to 3 months
Association between alcohol consumption and physical activity over time Time Frame: Up to 3 months	Correlation between average alcohol consumption and physical activity assessed using IPAQ-SF.	Up to 3 months
Association between alcohol consumption and sleep quality over time Time Frame: Up to 3 months	Correlation between average alcohol consumption and sleep quality assessed using the Mini Sleep Questionnaire (MSQ)	Up to 3 months
Association between alcohol consumption and contraceptive method Time Frame: Up to 3 months	Comparison of alcohol consumption patterns according to contraceptive method used.	Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

October 27, 2026

First Submitted That Met QC Criteria