Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-07 @ 1:11 AM
Study NCT ID:
NCT03485261
Status:
UNKNOWN
Last Update Posted:
2018-04-02
First Post:
2018-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Female Sexual Dysfunctions in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of female sexual dysfunctions in patients with chronic kidney disease.', 'timeFrame': 'one year', 'description': 'questionnaire to female patients with chronic kidney disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual abnormalities are common in CKD and many women are an-ovulatory.\n\nSexual dysfunction in CKD is multifactorial including hormonal alterations along with vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the development of sexual dysfunction. Sexual dysfunction in females is mainly due to hormonal factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal lubrication, and failure to conceive.', 'detailedDescription': 'The study will be conducted on 100 female patients divided in to two equal group:\n\n1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR \\<15ml/min/1.7m2 )\n2. Group B: The control group including 50 healthy females age matched with the patient group.\n\nThe Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.\n\nDuration of chronic kidney disease, duration of dialysis ,number of sessions of dialysis per week, medical treatment, haemoglobin,creatinine level will be fulfilled.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted on 100 female patients divided in to two equal group:\n\n1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR \\<15ml/min/1.7m2 )\n2. Group B: The control group including 50 healthy females age matched with the patient group.\n\nThe Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.\n\nDuration of chronic kidney disease, duration of dialysis, number of sessions of dialysis per week, medical treatment, haemoglobin, creatinine level will be fulfilled.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with chronic kidney disease stage 5 with estimated glomerular filtration rate (eGFR) \\<15 ml/min/1.7m2 using the equation of MDRD (modification of diet in renal disease) on dialysis or not.\n* Age from 18 to 45 years old.\n* Married.\n* Sexually active during the last 6 months.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Other medical diseases (diabetes mellitus, coronary artery disease, neurological disorders and other systematic diseases).\n* Taking medications affect sexuality function e.g. antidepressant drugs.'}, 'identificationModule': {'nctId': 'NCT03485261', 'briefTitle': 'Female Sexual Dysfunctions in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Sexual Dysfunctions in Female Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'FSDCKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'patient group include 50 female patients with chronic renal failure (eGFR \\<15ml/min/1.7m2 )'}, {'label': 'Group B', 'description': 'the control group including 50 healthy females age matched with the patient group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71621', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed samir, huxband', 'role': 'CONTACT', 'email': 'drahmedsamir3344@yahoo.com', 'phone': '01150730888'}], 'facility': 'Esraa Ahmed Mohamed', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'eamohamed', 'investigatorFullName': 'Esraa Ahmed Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}