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NCT06582212Recruiting

Enabling Women With Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms

Enabling Women With Parkinson's Disease to Identify and Better Manage Hormonal Triggers

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands. Studies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented. The investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and/or patient selfmanagement. Digital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment. Changes in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app. This will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
24 Jun 2024
Start date
12 Mar 2025
Primary completion date
12 Mar 2027
Lead sponsor
University Hospital, Grenoble
NCT number
NCT06582212

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 12 Mar 2025 to the primary completion date, 12 Mar 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures (i.e., dementia, severe depression, etc.)

Other

  • Post-menopausal women with PD
  • People not able to give an informed consent.

Who the study is looking for

  • Non-menopausal women
  • Diagnosis of PD according to the MDS criteria onset of PD symptoms since at least two years before inclusion
  • Age 18-56 years
  • On stable medication regimen for PD for at least two months without foreseen need to modify it within the next three months
  • With and without OCP or intrauterine devices (IUD

Age in the registry: 18 years to 56 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Grenoble Alpes
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
CHU Nantes Hôpital Laennec
Coordinator of this site? Confirm its status
NantesFranceRecruiting
CHU Rennes -Site Pontchaillou
Coordinator of this site? Confirm its status
RennesFranceRecruiting
CHU Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.