Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-05 @ 5:15 PM
Study NCT ID:
NCT06359457
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2024-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Serum Progesterone Level And Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum progesterone level', 'timeFrame': '1 month', 'description': 'Blood samples will be taken by physician for each girl, and will send to laboratory center to measure the progesterone level in the blood. The normal serum progesterone level at 21st day is 4-20 ng'}, {'measure': 'Pain intensity', 'timeFrame': '1 month', 'description': 'It will be measured by Visual analogue scale. It is 10 cm line with values ranging from 0 to 10. 0 indicates no pain nd 10 indicates the worst pain.'}, {'measure': 'Physical and psychological menstrual symptoms', 'timeFrame': '1 month', 'description': 'It will be measured by menstrual symptoms questionnaire. It is 25 items split into two categories which used to assess the physical and psychological symptoms associated with dysmenorrhea. The score on each item ranged from 1 (never) to 5 (always) with a higher composite score indicating more symptoms'}, {'measure': 'Correlation between serum progesterone level and pain', 'timeFrame': '1 month', 'description': 'The correlation between serum progesterone level and pain intensity measured by the VAS will be conducted'}, {'measure': 'Correlation between serum progesterone level and menstrual symptoms', 'timeFrame': '1 month', 'description': 'The correlation between serum progesterone level and menstrual symptoms measured by the menstrual symptom questionnaire will be conducted'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dysmenorrhoea', 'Serum progesterone level', 'Visual analogue scale', 'Menstrual symptoms questionnaire'], 'conditions': ['Primary Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to determine the correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females with primary dysmenorrhea.', 'detailedDescription': 'One hundred adult females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynaecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, Egypt Many studies reported that primary dysmenorrhea was the result of increased prostaglandin, especially prostaglandin F2α (PGF2α) and prostaglandin E2 (PGE2) which produced the effect through the cyclooxygenase pathway, and further led to uterine ischemia hypoxia. Nevertheless the relationship between the serum progesterone level and menstrual symptoms was not completely clear. Hence, this study will investigate the association between the serum progesterone level and menstrual symptoms in young females with primaryf dysmenorrhea.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '17 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred girls with dysmenorrhoea. Menarche at least 3 years ago. All females should be regular menstrual cycles.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. One hundreds adult females were suffered from primary dysmenorrhea.\n2. Their age was ranged from 17 to 24 years.\n3. Their body mass index was ranged from 20 to 25 kg/m2.\n\nExclusion Criteria:\n\n* Any participant will be excluded from the study if they have:\n\n 1. Irregulars or infrequent menstrual cycles.\n 2. Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis.\n 3. Pelvic pathology.'}, 'identificationModule': {'nctId': 'NCT06359457', 'briefTitle': 'Correlation Between Serum Progesterone Level And Primary Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between Serum Progesterone Level And Menstrual Symptoms In Young Females With Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A group of young females with primary dysmenorrhea', 'description': 'One hundred young females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, Egypt.\n\nAll females should have regular menstrual cycles. Taking blood samples of 3 ml through the cubital vein to examine the levels of serum progesterone will be carried out on the 21st day of menstruation, while to assess the pain intensity of primary dysmenorrhea using the Visual Analogue Scale (VAS) and physical and psychological symptoms associated with dysmenorrhea will be assessed by menstrual symptoms questionnaire\n\n.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Menna Allah Youssef Nasr El-Dien', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'HANAA HAFEZ, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Physical Therapy for Orthopedic. Physical Therapy, Nahda University.'}, {'name': 'RANIA Hamed, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Physical Therapy for Basic Science. Physical Therapy, Nahda University.'}, {'name': 'ESRAA MOHAMED, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer Of Physical Therapy For Cardiovascular, Respiratory and Geriatrics.'}, {'name': 'HOSSAM HUSSIEN, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Al-Azhar University.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Lecturer of physical therapy for women's health", 'investigatorFullName': 'Mennaallah Yousef Mohamed Nasreldien', 'investigatorAffiliation': 'Cairo University'}}}}