HealthyFEMMESNCT05028959
Hormonal Status, Performance and Health in Elite Female Athlete
A study testing Multidisciplinary monitoring of healthy women in people with Healthy, run by Université Paris-Saclay-Assistance publique des hôpitaux de Paris.
Trial summary
The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Multidisciplinary monitoring of healthy women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)
- Group 2: recreational athletes who practice a regular physical activity
Who cannot join
- Participation in another trial
- History of cardiac pathology
- High blood pressure
- History of ulcers and other gastrointestinal disorders
- Myasthenia
- Renal insufficiency
- Person not affiliated or not benefiting from a social security system
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport
The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group):
- 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;
- 2) the potential confounding effects of the athlete's environment
- 3) correlations between the different matrices analyzed
Read the detailed description
Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:
Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives
Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives
Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves.
Investigations to be performed:
- Annual complete clinical examination :
- "Out-of-competition" follow-up, time frame 6 months
- medical, nutritional and respiratory monitoring
- biological monitoring
- psychological monitoring
- performance monitoring
- Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:
- biological monitoring
- psychological monitoring
- performance monitoring (interview)
- Conditions
- Healthy
- Being tested
- Multidisciplinary monitoring of healthy women
- Keywords
- female elite athlete, menstrual phase, amenorrhea, hormonal contraception, performance, health, Athlete Biological Passport
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary monitoring of healthy womenOther
Multidisciplinary monitoring
| Study group | Role | What they receive |
|---|---|---|
| Female athletes | Experimental | highly trained subjects Receives: Other: Multidisciplinary monitoring of healthy women |
| Leisure sport women | Experimental | recreational sportswomen practicing regular physical activity Receives: Other: Multidisciplinary monitoring of healthy women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline weight
in kg, by impedancemeter
Measured: 6 months
Change from baseline fat and lean mass
in kg, by impedancemeter
Measured: 6 months
Change from baseline height
in cm, by height gauge
Measured: 6 months
Change from baseline sex and stress hormones
concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L
Measured: 6 months
Change from baseline food intake
food intake questionnaire to complete over 3 days, expressed in kcal/day
Measured: 6 months
Change from baseline metabolic parameters
concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L
Measured: 6 months
Change from baseline respiratory parameters
measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity
Measured: 6 months
Change from baseline inflammatory parameters
concentration of cytokines (TNF-alpha, IL-6) in mol/L
Measured: 6 months
Change from baseline executive function
assessed by instability via static and dynamic postures (eyes open/closed) on platform
Measured: 6 months
Change from baseline visual-spatial processing
3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score
Measured: 6 months
Change from baseline attention and working memory
Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention
Measured: 6 months
Change from baseline performance monitoring
field performance test, performance expressed in time
Measured: 6 months
Change from baseline Athlete Biological Passport (Group 2)
assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
Measured: 6 months
Change from baseline affects (Group 2)
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.
Measured: 6 months
Change from baseline anxiety (Group 2)
Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
Measured: 6 months
Change from baseline Athlete Biological Passport (Group 1)
assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
Measured: 8 months
Change from baseline affects (Group 1)
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.
Measured: 8 months
Change from baseline anxiety (Group 1)
Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
Measured: 8 months
Interview (Group 1)
Self-confrontation interview for questioning the action
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start15 Sep 2021 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups : female athletes and leisure sports women
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Paris-Saclay-Assistance publique des hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuelle Duron, Université Paris-Saclay-Assistance publique des hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028959
- Sponsor's protocol ID
- FEM-2020
- Acronym
- FEMMES
- Status last verified
- Aug 2021
- First submitted
- 21 Jun 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ackerman KE, Singhal V, Baskaran C, Slattery M, Campoverde Reyes KJ, Toth A, Eddy KT, Bouxsein ML, Lee H, Klibanski A, Misra M. Oestrogen replacement improves bone mineral density in oligo-amenorrhoeic athletes: a randomised clinical trial. Br J Sports Med. 2019 Feb;53(4):229-236. doi: 10.1136/bjsports-2018-099723. Epub 2018 Oct 9.
PubMed 30301734Crewther BT, Cook CJ. The salivary testosterone response to a chance-determined contest is associated with face-gazing behaviours in athletic women. Horm Behav. 2018 Jul;103:107-110. doi: 10.1016/j.yhbeh.2018.06.011. Epub 2018 Jul 2.
PubMed 29953884Casey E, Reese M, Okafor E, Chun D, Gagnon C, Nigl F, Dhaher YY. Influence of Menstrual Cycle and Oral Contraceptive Phase on Spinal Excitability. PM R. 2016 Sep;8(9):860-8. doi: 10.1016/j.pmrj.2016.01.013. Epub 2016 Feb 10.
PubMed 26872589Cornelli U, Belcaro G, Cesarone MR, Finco A. Analysis of oxidative stress during the menstrual cycle. Reprod Biol Endocrinol. 2013 Aug 2;11:74. doi: 10.1186/1477-7827-11-74.
PubMed 23915183Eklund E, Berglund B, Labrie F, Carlstrom K, Ekstrom L, Hirschberg AL. Serum androgen profile and physical performance in women Olympic athletes. Br J Sports Med. 2017 Sep;51(17):1301-1308. doi: 10.1136/bjsports-2017-097582. Epub 2017 Jun 23.
PubMed 28646101Emami F, Kordi Yoosefinejad A, Motealleh A. Comparison of static and dynamic balance during early follicular and ovulation phases in healthy women, using simple, clinical tests: a cross sectional study. Gynecol Endocrinol. 2019 Mar;35(3):257-260. doi: 10.1080/09513590.2018.1519788. Epub 2018 Oct 23.
PubMed 30350735Hausmann M, Slabbekoorn D, Van Goozen SH, Cohen-Kettenis PT, Gunturkun O. Sex hormones affect spatial abilities during the menstrual cycle. Behav Neurosci. 2000 Dec;114(6):1245-50. doi: 10.1037//0735-7044.114.6.1245.
PubMed 11142657Julian R, Hecksteden A, Fullagar HH, Meyer T. The effects of menstrual cycle phase on physical performance in female soccer players. PLoS One. 2017 Mar 13;12(3):e0173951. doi: 10.1371/journal.pone.0173951. eCollection 2017.
PubMed 28288203Kishali NF, Imamoglu O, Katkat D, Atan T, Akyol P. Effects of menstrual cycle on sports performance. Int J Neurosci. 2006 Dec;116(12):1549-63. doi: 10.1080/00207450600675217.
PubMed 17145688Kluft C, Leuven JA, Helmerhorst FM, Krans HM. Pro-inflammatory effects of oestrogens during use of oral contraceptives and hormone replacement treatment. Vascul Pharmacol. 2002 Aug;39(3):149-54. doi: 10.1016/s1537-1891(02)00304-x.
PubMed 12616983Langdeau JB, Day A, Turcotte H, Boulet LP. Gender differences in the prevalence of airway hyperresponsiveness and asthma in athletes. Respir Med. 2009 Mar;103(3):401-6. doi: 10.1016/j.rmed.2008.09.023. Epub 2008 Nov 21.
PubMed 19027280Lebrun CM, Petit MA, McKenzie DC, Taunton JE, Prior JC. Decreased maximal aerobic capacity with use of a triphasic oral contraceptive in highly active women: a randomised controlled trial. Br J Sports Med. 2003 Aug;37(4):315-20. doi: 10.1136/bjsm.37.4.315.
PubMed 12893716Nose-Ogura S, Yoshino O, Dohi M, Kigawa M, Harada M, Hiraike O, Onda T, Osuga Y, Fujii T, Saito S. Risk factors of stress fractures due to the female athlete triad: Differences in teens and twenties. Scand J Med Sci Sports. 2019 Oct;29(10):1501-1510. doi: 10.1111/sms.13464. Epub 2019 Jun 9.
PubMed 31100189Otaka M, Chen SM, Zhu Y, Tsai YS, Tseng CY, Fogt DL, Lim BH, Huang CY, Kuo CH. Does ovulation affect performance in tennis players? BMJ Open Sport Exerc Med. 2018 Jan 27;4(1):e000305. doi: 10.1136/bmjsem-2017-000305. eCollection 2018.
PubMed 29464104Schaumberg MA, Jenkins DG, Janse DE Jonge XA, Emmerton LM, Skinner TL. Oral Contraceptive Use Dampens Physiological Adaptations to Sprint Interval Training. Med Sci Sports Exerc. 2017 Apr;49(4):717-727. doi: 10.1249/MSS.0000000000001171.
PubMed 27898641
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport
- ClinicalTrials.gov ID
- NCT05028959
- Acronym / sponsor ID
- FEMMES / FEM-2020
- Conditions
- Healthy
- Keywords
- female elite athlete, menstrual phase, amenorrhea, hormonal contraception, performance, health, Athlete Biological Passport
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université Paris-Saclay-Assistance publique des hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group):
- 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;
- 2) the potential confounding effects of the athlete's environment
- 3) correlations between the different matrices analyzed
Detailed description
Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:
Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives
Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives
Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves.
Investigations to be performed:
- Annual complete clinical examination :
- "Out-of-competition" follow-up, time frame 6 months
- medical, nutritional and respiratory monitoring
- biological monitoring
- psychological monitoring
- performance monitoring
- Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:
- biological monitoring
- psychological monitoring
- performance monitoring (interview)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups : female athletes and leisure sports women
| Arm | Type | Receives |
|---|---|---|
| Female athletes | Experimental | Other: Multidisciplinary monitoring of healthy womenhighly trained subjects |
| Leisure sport women | Experimental | Other: Multidisciplinary monitoring of healthy womenrecreational sportswomen practicing regular physical activity |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)
- Group 2: recreational athletes who practice a regular physical activity
Key exclusion criteria (7 listed)
- Participation in another trial
- History of cardiac pathology
- High blood pressure
- History of ulcers and other gastrointestinal disorders
- Myasthenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary monitoring of healthy womenMultidisciplinary monitoring | Other | Female athletes, Leisure sport women |
Primary outcome
Change from baseline weight
Time frame: 6 months
in kg, by impedancemeter
Change from baseline fat and lean mass
Time frame: 6 months
in kg, by impedancemeter
Change from baseline height
Time frame: 6 months
in cm, by height gauge
Change from baseline sex and stress hormones
Time frame: 6 months
concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L
Change from baseline food intake
Time frame: 6 months
food intake questionnaire to complete over 3 days, expressed in kcal/day
Change from baseline metabolic parameters
Time frame: 6 months
concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L
Change from baseline respiratory parameters
Time frame: 6 months
measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity
Change from baseline inflammatory parameters
Time frame: 6 months
concentration of cytokines (TNF-alpha, IL-6) in mol/L
Change from baseline executive function
Time frame: 6 months
assessed by instability via static and dynamic postures (eyes open/closed) on platform
Change from baseline visual-spatial processing
Time frame: 6 months
3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score
Change from baseline attention and working memory
Time frame: 6 months
Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention
Change from baseline performance monitoring
Time frame: 6 months
field performance test, performance expressed in time
Change from baseline Athlete Biological Passport (Group 2)
Time frame: 6 months
assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
Change from baseline affects (Group 2)
Time frame: 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.
Change from baseline anxiety (Group 2)
Time frame: 6 months
Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
Change from baseline Athlete Biological Passport (Group 1)
Time frame: 8 months
assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
Change from baseline affects (Group 1)
Time frame: 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.
Change from baseline anxiety (Group 1)
Time frame: 8 months
Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
Interview (Group 1)
Time frame: 8 months
Self-confrontation interview for questioning the action
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Background: PubMed 30301734Ackerman KE, Singhal V, Baskaran C, Slattery M, Campoverde Reyes KJ, Toth A, Eddy KT, Bouxsein ML, Lee H, Klibanski A, Misra M. Oestrogen replacement improves bone mineral density in oligo-amenorrhoeic athletes: a randomised clinical trial. Br J Sports Med. 2019 Feb;53(4):229-236. doi: 10.1136/bjsports-2018-099723. Epub 2018 Oct 9.
- Background: PubMed 29953884Crewther BT, Cook CJ. The salivary testosterone response to a chance-determined contest is associated with face-gazing behaviours in athletic women. Horm Behav. 2018 Jul;103:107-110. doi: 10.1016/j.yhbeh.2018.06.011. Epub 2018 Jul 2.
- Background: PubMed 26872589Casey E, Reese M, Okafor E, Chun D, Gagnon C, Nigl F, Dhaher YY. Influence of Menstrual Cycle and Oral Contraceptive Phase on Spinal Excitability. PM R. 2016 Sep;8(9):860-8. doi: 10.1016/j.pmrj.2016.01.013. Epub 2016 Feb 10.
- Background: PubMed 23915183Cornelli U, Belcaro G, Cesarone MR, Finco A. Analysis of oxidative stress during the menstrual cycle. Reprod Biol Endocrinol. 2013 Aug 2;11:74. doi: 10.1186/1477-7827-11-74.
- Background: PubMed 28646101Eklund E, Berglund B, Labrie F, Carlstrom K, Ekstrom L, Hirschberg AL. Serum androgen profile and physical performance in women Olympic athletes. Br J Sports Med. 2017 Sep;51(17):1301-1308. doi: 10.1136/bjsports-2017-097582. Epub 2017 Jun 23.
- Background: PubMed 30350735Emami F, Kordi Yoosefinejad A, Motealleh A. Comparison of static and dynamic balance during early follicular and ovulation phases in healthy women, using simple, clinical tests: a cross sectional study. Gynecol Endocrinol. 2019 Mar;35(3):257-260. doi: 10.1080/09513590.2018.1519788. Epub 2018 Oct 23.
- Background: PubMed 11142657Hausmann M, Slabbekoorn D, Van Goozen SH, Cohen-Kettenis PT, Gunturkun O. Sex hormones affect spatial abilities during the menstrual cycle. Behav Neurosci. 2000 Dec;114(6):1245-50. doi: 10.1037//0735-7044.114.6.1245.
- Background: PubMed 28288203Julian R, Hecksteden A, Fullagar HH, Meyer T. The effects of menstrual cycle phase on physical performance in female soccer players. PLoS One. 2017 Mar 13;12(3):e0173951. doi: 10.1371/journal.pone.0173951. eCollection 2017.
- Background: PubMed 17145688Kishali NF, Imamoglu O, Katkat D, Atan T, Akyol P. Effects of menstrual cycle on sports performance. Int J Neurosci. 2006 Dec;116(12):1549-63. doi: 10.1080/00207450600675217.
- Background: PubMed 12616983Kluft C, Leuven JA, Helmerhorst FM, Krans HM. Pro-inflammatory effects of oestrogens during use of oral contraceptives and hormone replacement treatment. Vascul Pharmacol. 2002 Aug;39(3):149-54. doi: 10.1016/s1537-1891(02)00304-x.
- Background: PubMed 19027280Langdeau JB, Day A, Turcotte H, Boulet LP. Gender differences in the prevalence of airway hyperresponsiveness and asthma in athletes. Respir Med. 2009 Mar;103(3):401-6. doi: 10.1016/j.rmed.2008.09.023. Epub 2008 Nov 21.
- Background: PubMed 12893716Lebrun CM, Petit MA, McKenzie DC, Taunton JE, Prior JC. Decreased maximal aerobic capacity with use of a triphasic oral contraceptive in highly active women: a randomised controlled trial. Br J Sports Med. 2003 Aug;37(4):315-20. doi: 10.1136/bjsm.37.4.315.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary monitoring of healthy women in people with Healthy, run by Université Paris-Saclay-Assistance publique des hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle DURON, PU-PH (33144083503, emmanuelle.duron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline weight (time frame: 6 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028959, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.