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Not yet recruitingNCT07910643FLOWUpdated Nov 3, 2026

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

An observational study in Alcohol Use, Alcohol Consumption and Menstrual Cycle, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Primary conditionAlcohol Drinking(the registry's first term)UnverifiedIs this wrong?Alcohol Drinking is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Hospices Civils de Lyon · Observational

Updated Nov 3, 2026Start date movedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Alcohol Use
  • Alcohol Consumption
  • Menstrual Cycle
  • Women's Health

Keywords

  • Menstrual Cycle
  • Alcohol Consumption
  • Anxiety
  • Physical activity
  • Sleep quality
  • Contraceptive method
03

In context

Alcohol Drinking Unverified

940 studies on the registry are indexed under Alcohol Drinking; 171 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 227 across 94 observational studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,863 studies on the registry; 445 are open to participants now.

Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women from the general population with regular menstrual cycles.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Occurrence of an alcohol consumption day

    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

    Time frame: Up to 3 months

Secondary outcomes

  1. Number of binge drinking days

    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.

    Time frame: Up to 3 months

  2. Association between alcohol consumption and anxiety levels over time

    Correlation between average alcohol consumption and anxiety levels assessed using GAD-7 throughout the menstrual cycle.

    Time frame: Up to 3 months

  3. Association between alcohol consumption and physical activity over time

    Correlation between average alcohol consumption and physical activity assessed using IPAQ-SF.

    Time frame: Up to 3 months

  4. Association between alcohol consumption and sleep quality over time

    Correlation between average alcohol consumption and sleep quality assessed using the Mini Sleep Questionnaire (MSQ)

    Time frame: Up to 3 months

  5. Association between alcohol consumption and contraceptive method

    Comparison of alcohol consumption patterns according to contraceptive method used.

    Time frame: Up to 3 months

07

Study locations

1 site
  • Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
    Pierre-Bénite, 69495, France
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for May 2027, 3 months later.

Of 50 non-industry observational studies under Alcohol Drinking, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 65. This study's planned 3 months is below that.

Counting every sponsor, half of 50 studies reached it within 45 months; a quarter within 25 and three quarters within 65.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: start Jan 2027 → Feb 2027, primary completion Apr 2027 → May 2027 and completion Apr 2027 → May 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 2, 2026
StartEst.
Feb 2027was Jan 2027
Primary completionEst.
May 2027was Apr 2027
CompletionEst.
May 2027was Apr 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jan 2027→Feb 2027
Nov 3, 2026
Primary completion
Apr 2027→May 2027
Nov 3, 2026
Study completion
Apr 2027→May 2027
Nov 3, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 3, 2026
    Start date Jan 2027→Feb 2027
    Primary completion Apr 2027→May 2027
    Study completion Apr 2027→May 2027
    + 1 other change: verification date
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07910643
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Feb 2027 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Valentine LHORTOLAT, Midwife
Contact
valentine.lhortolat@chu-lyon.fr
4 78 86 41 00 ext. +33
Benjamin ROLLAND, MD
Contact
Benjamin.rolland@chu-lyon.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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