Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 5:56 PM
Study NCT ID:
NCT04941833
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2021-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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': 'D017135', 'term': 'Desogestrel'}], 'ancestors': [{'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-18', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of the drug in the study', 'timeFrame': '3 months after drug given', 'description': 'Effect of the oral desogestrel and placebo such as spotting, weight gain, wood swing'}], 'primaryOutcomes': [{'measure': 'Cyst diameter', 'timeFrame': '3 months after drug given', 'description': 'Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)'}], 'secondaryOutcomes': [{'measure': 'Associated pain', 'timeFrame': '3 months after drug given', 'description': 'Associated pain is measured by the visual analog score. The patients will record the score on the book everytimes when they have pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrioma']}, 'referencesModule': {'references': [{'pmid': '31304853', 'type': 'BACKGROUND', 'citation': 'Muzii L, Galati G, Di Tucci C, Di Feliciantonio M, Perniola G, Di Donato V, Benedetti Panici P, Vignali M. Medical treatment of ovarian endometriomas: a prospective evaluation of the effect of dienogest on ovarian reserve, cyst diameter, and associated pain. Gynecol Endocrinol. 2020 Jan;36(1):81-83. doi: 10.1080/09513590.2019.1640199. Epub 2019 Jul 14.'}, {'pmid': '23580011', 'type': 'BACKGROUND', 'citation': 'Cucinella G, Granese R, Calagna G, Svelato A, Saitta S, Tonni G, De Franciscis P, Colacurci N, Perino A. Oral contraceptives in the prevention of endometrioma recurrence: does the different progestins used make a difference? Arch Gynecol Obstet. 2013 Oct;288(4):821-7. doi: 10.1007/s00404-013-2841-9. Epub 2013 Apr 12.'}, {'pmid': '26115056', 'type': 'BACKGROUND', 'citation': 'Taniguchi F, Enatsu A, Ota I, Toda T, Arata K, Harada T. Effects of low dose oral contraceptive pill containing drospirenone/ethinylestradiol in patients with endometrioma. Eur J Obstet Gynecol Reprod Biol. 2015 Aug;191:116-20. doi: 10.1016/j.ejogrb.2015.06.006. Epub 2015 Jun 16.'}, {'pmid': '16963174', 'type': 'BACKGROUND', 'citation': 'Razzi S, Luisi S, Ferretti C, Calonaci F, Gabbanini M, Mazzini M, Petraglia F. Use of a progestogen only preparation containing desogestrel in the treatment of recurrent pelvic pain after conservative surgery for endometriosis. Eur J Obstet Gynecol Reprod Biol. 2007 Dec;135(2):188-90. doi: 10.1016/j.ejogrb.2006.08.002. Epub 2006 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.', 'detailedDescription': 'Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months in Rajvithi hospital Patient will randomized in 2 group : Desogestrel and placebo After 1 months and 3 months the patient have to come to hospital to evaluate the result of study The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thai female and foreigner who can understand Thai language\n* Age 15-49 years\n* Diagnose as endometrioma sized more than 3 cm\n* Underwent to surgery in next 13 weeks\n\nExclusion Criteria:\n\n* History of endometriosis\n* Pregnancy woman\n* Contraindication for desogestrel : History of thrombotic event, Autoimmune disease,gestational trophoblastic disease\n* Ovarian endometrioma with complications : Ruptured, twisted\n* Contraindications for NSAIDs : Peptic ulcer, thrombocytopenia, liver disease\n* History of hormonal treatment for endometrioma : DMPA,OCP, GNRH agonist/antoginist'}, 'identificationModule': {'nctId': 'NCT04941833', 'briefTitle': 'Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'The Use of Oral Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo : A Randomized Controlled Trial Evaluation of the Effect on Cyst Diameter and Associated Pain', 'orgStudyIdInfo': {'id': '147/2564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desogestrel group', 'description': 'Desogestrel group', 'interventionNames': ['Drug: Desogestrel Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo', 'interventionNames': ['Drug: Desogestrel Oral Tablet']}], 'interventions': [{'name': 'Desogestrel Oral Tablet', 'type': 'DRUG', 'otherNames': ['Cerazette'], 'description': 'Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel', 'armGroupLabels': ['Control group', 'Desogestrel group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Ratchadaporn Roekyindee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Medical Services Ministry of Public Health of Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}