Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 6:54 AM
Study NCT ID:
NCT01942369
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
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': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D007273', 'term': 'Injections, Intramuscular'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-16'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-10', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery', 'timeFrame': 'Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months', 'description': 'The specific endometriosis symptoms include pelvic pain, dysmenorrhoea, pain at time of ovulation, dyspareunia to be assessed with a 10-cm visual analogue scale (VAS).\n\nOther symptoms (Amenorrhea, menorrhagia, metrorrhagia, Global GI symptoms \\& urinary discomfort,) will be assessed by oral enquiry to the patients based on numerical scale from 0 to 10 (0 being the best and 10 the worst status).'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate of specific endometriosis symptoms', 'timeFrame': 'At 12 months and 24 months', 'description': 'Recurrence rate of specific endometriosis symptoms in the group of patients with mild or null symptoms score following surgery and Diphereline treatment.'}, {'measure': 'Change during the study period in symptom(s) having the highest intensity at baseline', 'timeFrame': '24 months', 'description': 'The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment.'}, {'measure': 'Rate of pregnancy in subjects', 'timeFrame': 'At 12 months and 24 months'}, {'measure': 'Abdominal pain-free interval', 'timeFrame': 'Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months', 'description': 'Assessed using a visual analogue scale (VAS).'}, {'measure': 'Disease profile of DIE patients treated by Diphereline and by duration of treatment.', 'timeFrame': '24 months', 'description': 'The disease profile (size of the lesion, locations etc…) will be detailed in each group of treatment duration by descriptive statistics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endometriosis'], 'conditions': ['Deep Infiltrating Endometriosis (DIE)']}, 'referencesModule': {'references': [{'pmid': '35119037', 'type': 'DERIVED', 'citation': 'Zhu L, Guan Z, Huang Y, Hua K, Ma L, Zhang J, Yang D, Perrot V, Li H, Zhang X. The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China. Medicine (Baltimore). 2022 Feb 4;101(5):e28766. doi: 10.1097/MD.0000000000028766.'}, {'pmid': '34397719', 'type': 'DERIVED', 'citation': 'Sun W, Hua K, Hong L, Zhang J, Hao M, Wang J, Zhang J, Perrot V, Li H, Zhang X. Symptom control after different duration of triptorelin treatment following conservative surgery for deep infiltrating endometriosis: Post-hoc analysis of a multicentre, prospective, real-world study. Medicine (Baltimore). 2021 Jul 30;100(30):e26753. doi: 10.1097/MD.0000000000026753.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital patients who had been diagnosed with DIE, surgically treated and for whom decision has been made to be treated with a GnRHa post-surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with DIE and having received surgery treatment within one month before inclusion\n* Premenopausal women aged \\>=18 years old.\n* Written ICF has been obtained prior to any study-related procedures\n* Patient for whom the treating physician already made the decision to treat by Diphereline.\n* Patient should be mentally and physically able to express her symptom complaints and answer questions.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Patients currently on treatment or who have been on therapy with a GnRHa in the last 6 months.\n* Premenopausal women who may reach menopause within the 3 years post randomisation.\n* Hypersensitivity to Triptorelin or one of the excipients of Triptorelin 3.75mg\n* Treatment with another research drug over the last 3 months before the study\n* Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT01942369', 'acronym': 'DIE-NIS', 'briefTitle': 'A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Multi-centre, Prospective, Non-interventional Study to Describe the Efficacy of a Continuous up to 24-week Treatment of Diphereline 3.75mg Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months.', 'orgStudyIdInfo': {'id': 'A-38-52014-210'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Deep Infiltrating Endometriosis (DIE)', 'interventionNames': ['Drug: Triptorelin Acetate 3.75mg intramuscular injection']}], 'interventions': [{'name': 'Triptorelin Acetate 3.75mg intramuscular injection', 'type': 'DRUG', 'otherNames': ['Diphereline 3.75mg intramuscular injection'], 'description': 'Triptorelin Acetate is a Gonadotrophin Releasing Hormone agonist (GnRHa).\n\nTriptorelin acetate for injection 3.75mg administered as described in the patient information sheet approved in China: one intramuscular injection of the product repeated every 4 weeks.', 'armGroupLabels': ['Deep Infiltrating Endometriosis (DIE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100096', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Jishuitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400037', 'city': 'Chongqing', 'country': 'China', 'facility': 'Xinqiao Hospital,Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400038', 'city': 'Chongqing', 'country': 'China', 'facility': 'Southwest Hospital,Chongqing,400038', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '310006', 'city': 'Hangzhou', 'country': 'China', 'facility': "Women's Hospital, School of Medicine, Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '230031', 'city': 'Hefei', 'country': 'China', 'facility': 'Anhui Provincial Cancer Hospital,Hefei,China,230031', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '330008', 'city': 'Nanchang', 'country': 'China', 'facility': 'Jiangxi Maternal and Child Health Hospital,Nanchang', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '210011', 'city': 'Nanjing', 'country': 'China', 'facility': 'Nanjing Maternity and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200011', 'city': 'Shanghai', 'country': 'China', 'facility': 'Obstetrics and Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200030', 'city': 'Shanghai', 'country': 'China', 'facility': 'The International Peace Maternity & Child Health Hospital of China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201204', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai First Maternity and Infant Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '518020', 'city': 'Shenzhen', 'country': 'China', 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '030001', 'city': 'Taiyuan', 'country': 'China', 'facility': 'The Second Hospital of Shanxi Medical University,Taiyuan', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '430022', 'city': 'Wuhan', 'country': 'China', 'facility': 'Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430060', 'city': 'Wuhan', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University (Hubei General Hospital)', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '450008', 'city': 'Zhengzhou', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}