NCT06910774

Brief Summary

The goal of this observational study is to measure serotonin levels in in a control cohort. The main question aims to determine the mean serum serotonin level in a cohort of adult controls, based on age and sex. This will allow for the establishment of reference values. We will also measure the different metabolites of tryptophan. These measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Thus, patients will not need to undergo an additional blood draw.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

March 28, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

serotonin (5-HT)tryptophancontrol cohortagesexiron status

Outcome Measures

Primary Outcomes (1)

  • Serotonin

    Measurement of serotonin levels in serum (HPLC: high performance liquid chromatography)

    at day 0

Secondary Outcomes (1)

  • Tryptophan metabolites

    at day 0

Study Arms (1)

control cohort

* Adult patients aged ≥ 18 years * Who have undergone a blood draw at CHSF during the recruitment period * With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges * With a C-reactive protein (CRP) level \< 30 mg/L

Other: Dosage of serotonin and tryptophan metabolites levels in serum

Interventions

These measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Patients will not need to undergo an additional blood draw.

control cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is a control cohort. We will include adult patients aged 18 years or older who have undergone a blood draw at CHSF during the recruitment period. Eligible participants must have hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges, and a C-reactive protein (CRP) level below 30 mg/L.

You may qualify if:

  • Adult patients aged ≥ 18 years
  • Who have undergone a blood draw at CHSF during the recruitment period
  • With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges
  • With a C-reactive protein (CRP) level \< 30 mg/L

You may not qualify if:

  • Patients informed about the study who decline participation
  • Patients with a current diagnosis or history of psychiatric disorders
  • Patients on antidepressants or narcotics at the time of sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91110, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The remaining blood samples from the samples taken as part of the treatment will be the subject of a biological collection

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Guillemette FOUQUET, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

June 23, 2025

Primary Completion

November 16, 2025

Study Completion

November 16, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations