Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-12 @ 10:06 PM
Study NCT ID:
NCT02794467
Status:
WITHDRAWN
Last Update Posted:
2017-01-18
First Post:
2016-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571185', 'term': 'epelsiban'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "Study was prematurely discontinued due to GSK's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3', 'timeFrame': 'Baseline and end of menses Cycle 3 (approximately 12 weeks)', 'description': 'MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle'}, {'measure': 'Number of subjects with adverse events (AE)', 'timeFrame': 'Up to 3 months', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3', 'timeFrame': 'Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)', 'description': 'MBL will be measured from blood collected from menstrual cycle by-products'}, {'measure': 'Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle', 'timeFrame': 'Up to 3 months', 'description': 'Average daily dysmenorrhea score from Day -1 to Day 2 of menses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heavy menstrual bleeding', 'Adenomyosis', 'Safety', 'Epelsiban', 'Tolerability', 'Proof of concept'], 'conditions': ['Adenomyosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.\n\nThis is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eighteen to 55 years of age, inclusive\n* Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.\n* Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .\n* Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.\n* Not pregnant as confirmed by a negative serum human chorionic gonadotropin\n\nExclusion Criteria:\n\n* A female subject will not be eligible for inclusion in this study if any of the following criteria apply:\n* Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start\n* Abnormal endometrial biopsy within six months of starting study treatment.\n* History of an endometrial ablation within 12 months of starting study treatment.\n* Uterine artery embolization within six months of starting study treatment.\n* Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).\n* Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.\n* Active pelvic infection or current use of an intrauterine device within three months of screening.\n* Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.\n* Any uterine dimension \\>20 centimeter (cm).\n* Other major causes of heavy menstrual bleeding -\n* Use within 3 months or anticipated use of medications that modify reproductive function\n* Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.\n* Use of daily opioid pain medications other than with menses.\n* Hemoglobin \\<8 grams (g)/deciliter.\n* History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).'}, 'identificationModule': {'nctId': 'NCT02794467', 'briefTitle': 'Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis', 'orgStudyIdInfo': {'id': '201580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epelsiban 75 mg', 'description': 'Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration', 'interventionNames': ['Drug: Epelsiban']}, {'type': 'EXPERIMENTAL', 'label': 'Epelsiban 200 mg', 'description': 'Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration', 'interventionNames': ['Drug: Epelsiban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Approximately 24 subjects will receive a matching placebo TID via oral administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Epelsiban', 'type': 'DRUG', 'description': 'Epelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing', 'armGroupLabels': ['Epelsiban 200 mg', 'Epelsiban 75 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '70471', 'city': 'Mandeville', 'state': 'Louisiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.35825, 'lon': -90.06563}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45322', 'city': 'Englewood', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.87756, 'lon': -84.30217}}, {'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}