Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT04287205
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2020-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004394', 'term': 'Dydrogesterone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2020-02-23', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effect of Dydrogesterone on Sexual Function', 'timeFrame': '6 months', 'description': 'In this study, we compare the fsfi(female sexual function index) questions and the scores before and after dihydrogestreone treatment in patients with endometriosis. We aim to measure the effect of dihydrogesterone in patients with endometriosis.'}], 'secondaryOutcomes': [{'measure': 'The Effect of Dydrogesterone on Sexual Function in women with endometrioma', 'timeFrame': '6 months', 'description': 'In this study, we compare the fsfi(female sexual function index) questions and the scores before and after dihydrogestreone treatment in patients with endometriosis. We aim to measure the effect of dihydrogesterone in patients with endometriosis.(with and without endometrioma)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the effects of dydrogesterone on sexual function in women with endometriosis using Female Function Sexual Index (FSFI).', 'detailedDescription': 'Sexual dysfunction is an important outcome for patients with endometriosis. In this study, we compare the fsfi (female sexual function index) questions and the scores before and after dydrogesterone treatment in patients with endometriosis. We aim to measure the effect of dydrogesterone in patients with endometriosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no history of malignancies,\n* normal findings at gynecological examinations and transvaginal ultrasonography\n* normal uterine size, normal cervical smear results,\n* patients not use any contraception methods in the last 6 months\n\nExclusion Criteria:\n\n* with a history of systemic and/or psychiatric diseases,\n* gynecological pathologies (myoma uteri, endometriosis, uterine anomalies, existing genital infections)\n* pelvic organ prolapse\n* pelvic surgeries'}, 'identificationModule': {'nctId': 'NCT04287205', 'briefTitle': 'The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis', 'orgStudyIdInfo': {'id': 'endo-fsfi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'women with endometriosis', 'interventionNames': ['Drug: Dydrogesterone']}], 'interventions': [{'name': 'Dydrogesterone', 'type': 'DRUG', 'description': '79 women, aged between 18 and 45 years, who were examined at our tertiary gynecology outpatient clinic between April 2019 and March 2020, with surgically diagnosed endometriosis, were included in this study. They received a treatment with 5 mg dydrogesterone administered orally twice daily for 21 days; from the 5th to 25th day of each menstrual cycle, for a total of 6 months. They were evaluated pre- and posttreatment in terms of their age, parity, and body mass index (BMI). Female Function Sexual Index (FSFI) and visual analogue scale (VAS) scores were recorded pre- and posttreatment', 'armGroupLabels': ['women with endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pinar Yalcin Bahat', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pınar Yalcin bahat', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}