Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-31 @ 4:36 PM
Study NCT ID:
NCT05028959
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hormonal Status, Performance and Health in Elite Female Athlete
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000568', 'term': 'Amenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups : female athletes and leisure sports women'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline weight', 'timeFrame': '6 months', 'description': 'in kg, by impedancemeter'}, {'measure': 'Change from baseline fat and lean mass', 'timeFrame': '6 months', 'description': 'in kg, by impedancemeter'}, {'measure': 'Change from baseline height', 'timeFrame': '6 months', 'description': 'in cm, by height gauge'}, {'measure': 'Change from baseline sex and stress hormones', 'timeFrame': '6 months', 'description': 'concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L'}, {'measure': 'Change from baseline food intake', 'timeFrame': '6 months', 'description': 'food intake questionnaire to complete over 3 days, expressed in kcal/day'}, {'measure': 'Change from baseline metabolic parameters', 'timeFrame': '6 months', 'description': 'concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L'}, {'measure': 'Change from baseline respiratory parameters', 'timeFrame': '6 months', 'description': 'measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity'}, {'measure': 'Change from baseline inflammatory parameters', 'timeFrame': '6 months', 'description': 'concentration of cytokines (TNF-alpha, IL-6) in mol/L'}, {'measure': 'Change from baseline executive function', 'timeFrame': '6 months', 'description': 'assessed by instability via static and dynamic postures (eyes open/closed) on platform'}, {'measure': 'Change from baseline visual-spatial processing', 'timeFrame': '6 months', 'description': '3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score'}, {'measure': 'Change from baseline attention and working memory', 'timeFrame': '6 months', 'description': 'Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention'}, {'measure': 'Change from baseline performance monitoring', 'timeFrame': '6 months', 'description': 'field performance test, performance expressed in time'}, {'measure': 'Change from baseline Athlete Biological Passport (Group 2)', 'timeFrame': '6 months', 'description': 'assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)'}, {'measure': 'Change from baseline affects (Group 2)', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Change from baseline anxiety (Group 2)', 'timeFrame': '6 months', 'description': 'Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety'}, {'measure': 'Change from baseline Athlete Biological Passport (Group 1)', 'timeFrame': '8 months', 'description': 'assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)'}, {'measure': 'Change from baseline affects (Group 1)', 'timeFrame': '8 months', 'description': '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.'}, {'measure': 'Change from baseline anxiety (Group 1)', 'timeFrame': '8 months', 'description': 'Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety'}, {'measure': 'Interview (Group 1)', 'timeFrame': '8 months', 'description': 'Self-confrontation interview for questioning the action'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['female elite athlete', 'menstrual phase', 'amenorrhea', 'hormonal contraception', 'performance', 'health', 'Athlete Biological Passport'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '30301734', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29953884', 'type': 'BACKGROUND', 'citation': 'Crewther 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.'}, {'pmid': '26872589', 'type': 'BACKGROUND', 'citation': 'Casey 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.'}, {'pmid': '23915183', 'type': 'BACKGROUND', 'citation': 'Cornelli 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.'}, {'pmid': '28646101', 'type': 'BACKGROUND', 'citation': 'Eklund 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.'}, {'pmid': '30350735', 'type': 'BACKGROUND', 'citation': 'Emami 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.'}, {'pmid': '11142657', 'type': 'BACKGROUND', 'citation': 'Hausmann 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.'}, {'pmid': '28288203', 'type': 'BACKGROUND', 'citation': 'Julian 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.'}, {'pmid': '17145688', 'type': 'BACKGROUND', 'citation': 'Kishali 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.'}, {'pmid': '12616983', 'type': 'BACKGROUND', 'citation': 'Kluft 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.'}, {'pmid': '19027280', 'type': 'BACKGROUND', 'citation': 'Langdeau 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.'}, {'pmid': '12893716', 'type': 'BACKGROUND', 'citation': 'Lebrun 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.'}, {'pmid': '31100189', 'type': 'BACKGROUND', 'citation': 'Nose-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.'}, {'pmid': '29464104', 'type': 'BACKGROUND', 'citation': 'Otaka 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.'}, {'pmid': '27898641', 'type': 'BACKGROUND', 'citation': 'Schaumberg 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.'}]}, 'descriptionModule': {'briefSummary': "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):\n\n* 1\\) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;\n* 2\\) the potential confounding effects of the athlete's environment\n* 3\\) correlations between the different matrices analyzed", 'detailedDescription': 'Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:\n\nGroup 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives\n\nGroup 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives\n\nFollowing 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.\n\nInvestigations to be performed:\n\n1. Annual complete clinical examination :\n2. "Out-of-competition" follow-up, time frame 6 months\n\n * medical, nutritional and respiratory monitoring\n * biological monitoring\n * psychological monitoring\n * performance monitoring\n3. Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:\n\n * biological monitoring\n * psychological monitoring\n * performance monitoring (interview)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)\n* Group 2: recreational athletes who practice a regular physical activity\n\nExclusion Criteria:\n\n* Participation in another trial\n* History of cardiac pathology\n* High blood pressure\n* History of ulcers and other gastrointestinal disorders\n* Myasthenia\n* Renal insufficiency\n* Person not affiliated or not benefiting from a social security system'}, 'identificationModule': {'nctId': 'NCT05028959', 'acronym': 'FEMMES', 'briefTitle': 'Hormonal Status, Performance and Health in Elite Female Athlete', 'organization': {'class': 'OTHER', 'fullName': 'Université Paris-Saclay-Assistance publique des hôpitaux de Paris'}, 'officialTitle': "Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport", 'orgStudyIdInfo': {'id': 'FEM-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Female athletes', 'description': 'highly trained subjects', 'interventionNames': ['Other: Multidisciplinary monitoring of healthy women']}, {'type': 'EXPERIMENTAL', 'label': 'Leisure sport women', 'description': 'recreational sportswomen practicing regular physical activity', 'interventionNames': ['Other: Multidisciplinary monitoring of healthy women']}], 'interventions': [{'name': 'Multidisciplinary monitoring of healthy women', 'type': 'OTHER', 'description': 'Multidisciplinary monitoring', 'armGroupLabels': ['Female athletes', 'Leisure sport women']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emmanuelle DURON, PU-PH', 'role': 'CONTACT', 'email': 'emmanuelle.duron@aphp.fr', 'phone': '33144083503'}, {'name': 'Christine Le-Scanff, PU', 'role': 'CONTACT', 'email': 'christine.le-scanff@universite-paris-saclay.fr', 'phone': '33169156198'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Paris-Saclay-Assistance publique des hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Geriatry, Principal investigator', 'investigatorFullName': 'Emmanuelle Duron', 'investigatorAffiliation': 'Université Paris-Saclay-Assistance publique des hôpitaux de Paris'}}}}