Hormonal Status, Performance and Health in Elite Female Athlete
NCT05028959, Not applicable, Unknown, Université Paris-Saclay-Assistance publique des hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Hormonal Status, Performance and Health in Elite Female Athlete | ClinicalTrials.gov |
| NCT number | NCT05028959 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Université Paris-Saclay-Assistance publique des hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Healthy | ClinicalTrials.gov |
| Interventions | Multidisciplinary monitoring of healthy women | ClinicalTrials.gov |
| First posted | 2021-08-31 | ClinicalTrials.gov |
| Last updated | 2021-08-31 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline weight | 6 months | in kg, by impedancemeter | ClinicalTrials.gov |
| Primary | Change from baseline fat and lean mass | 6 months | in kg, by impedancemeter | ClinicalTrials.gov |
| Primary | Change from baseline height | 6 months | in cm, by height gauge | ClinicalTrials.gov |
| Primary | Change from baseline sex and stress hormones | 6 months | concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L | ClinicalTrials.gov |
| Primary | Change from baseline food intake | 6 months | food intake questionnaire to complete over 3 days, expressed in kcal/day | ClinicalTrials.gov |
| Primary | Change from baseline metabolic parameters | 6 months | concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L | ClinicalTrials.gov |
| Primary | Change from baseline respiratory parameters | 6 months | measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity | ClinicalTrials.gov |
| Primary | Change from baseline inflammatory parameters | 6 months | concentration of cytokines (TNF-alpha, IL-6) in mol/L | ClinicalTrials.gov |
| Primary | Change from baseline executive function | 6 months | assessed by instability via static and dynamic postures (eyes open/closed) on platform | ClinicalTrials.gov |
| Primary | Change from baseline visual-spatial processing | 6 months | 3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score | ClinicalTrials.gov |
| Primary | Change from baseline attention and working memory | 6 months | Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention | ClinicalTrials.gov |
| Primary | Change from baseline performance monitoring | 6 months | field performance test, performance expressed in time | ClinicalTrials.gov |
| Primary | Change from baseline Athlete Biological Passport (Group 2) | 6 months | assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA) | ClinicalTrials.gov |
| Primary | Change from baseline affects (Group 2) | 6 months | Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Primary | Change from baseline anxiety (Group 2) | 6 months | Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety | ClinicalTrials.gov |
| Primary | Change from baseline Athlete Biological Passport (Group 1) | 8 months | assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA) | ClinicalTrials.gov |
| Primary | Change from baseline affects (Group 1) | 8 months | Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect. | ClinicalTrials.gov |
| Primary | Change from baseline anxiety (Group 1) | 8 months | Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety | ClinicalTrials.gov |
| Primary | Interview (Group 1) | 8 months | Self-confrontation interview for questioning the action | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 15
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 11142657 | BACKGROUND | PubMed |
| 12616983 | BACKGROUND | PubMed |
| 12893716 | BACKGROUND | PubMed |
| 17145688 | BACKGROUND | PubMed |
| 19027280 | BACKGROUND | PubMed |
| 23915183 | BACKGROUND | PubMed |
| 26872589 | BACKGROUND | PubMed |
| 27898641 | BACKGROUND | PubMed |
| 28288203 | BACKGROUND | PubMed |
| 28646101 | BACKGROUND | PubMed |
| 29464104 | BACKGROUND | PubMed |
| 29953884 | BACKGROUND | PubMed |
| 30301734 | BACKGROUND | PubMed |
| 30350735 | BACKGROUND | PubMed |
| 31100189 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Mental Rotation | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)