Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT06279195
Status:
WITHDRAWN
Last Update Posted:
2025-08-28
First Post:
2024-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561634', 'term': 'relugolix'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants in two groups with different conditions will be give REL-CT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Could not obtain approval for the planned study with available funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between post-treatment pelvic pain and baseline uterine contraction frequency', 'timeFrame': '6 months', 'description': 'At baseline before intervention, the number of contractions over a 10 minute period will be measured with MRI.Participants will complete a pain diaries before REL-CT treatment and 6 months after starting REL-CT treatment. Participants will be asked to rate their overall pelvic, bladder test pain and bowel pain at the end of the day via REDCap (on 0-10 scale, 0 no pain, 10 worst pain imaginable). The average pain ratings during non-menstrual days will be used to generate continuous ratings of pelvic pain for each diary. The correlation coefficient between the amount of contractions measured with MRI and average non-menstrual pelvic pain will be calculated.'}, {'measure': 'Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score.', 'timeFrame': '6 months', 'description': 'A composite Z-scored total sensory hypersensitivity score will be calculated by summing the z-scores obtained from the baseline sensory tests during bladder pain, bodily pressure pain threshold, and visual/audio tests at baseline. The correlation coefficient between the Z-scored total sensory hypersensitivity scored and average non-menstrual pelvic pain will be calculated.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Pelvic Pain', 'Pelvic Pain'], 'conditions': ['Pelvic Pain']}, 'referencesModule': {'references': [{'pmid': '29409786', 'type': 'BACKGROUND', 'citation': 'Hellman KM, Kuhn CS, Tu FF, Dillane KE, Shlobin NA, Senapati S, Zhou X, Li W, Prasad PV. Cine MRI during spontaneous cramps in women with menstrual pain. Am J Obstet Gynecol. 2018 May;218(5):506.e1-506.e8. doi: 10.1016/j.ajog.2018.01.035. Epub 2018 Feb 2.'}, {'pmid': '34510138', 'type': 'BACKGROUND', 'citation': 'Kmiecik MJ, Tu FF, Silton RL, Dillane KE, Roth GE, Harte SE, Hellman KM. Cortical mechanisms of visual hypersensitivity in women at risk for chronic pelvic pain. Pain. 2022 Jun 1;163(6):1035-1048. doi: 10.1097/j.pain.0000000000002469. Epub 2021 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing.', 'detailedDescription': 'The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with real-time uterine imaging techniques and quantitative sensory testing. Advanced MRI methodology enables the assessment of various uterine parameters, including contractions, peristalsis, perfusion, blood oxygenation, and structural factors. Importantly, it is possible to temporally correlate these mechanisms with self-reported spontaneous menstrual cramping pain through real-time imaging.\n\nIn the first aim of this proposal (Aim #1), mechanisms underlying unexplained menstrual pain phenotypes linked to deficiencies in myometrial activity, perfusion, and oxygenation and evaluate the subsequent impact of REL-CT will be evaluated. Aim #2 focuses on characterizing unexplained menstrual pain phenotypes associated with impairments in the central nervous system sensory functions and the effects of REL-CT. Quantitative sensory testing methods will be used to comprehensively assesses peripheral, central ascending, central integrating, and central descending nervous system components related to pelvic pain. In the past, this testing can identify central nervous system component pain that predicts the pain trajectory and corresponds with treatment outcomes.\n\nBy analyzing the relationship between the variable effectiveness of REL-CT treatment to observed mechanisms in menstrual pain, it may possible to identify specific unexplained pelvic pain phenotypes amenable to medical management. Furthermore, because that the precise mechanisms by which REL-CT alleviates menstrual pain in endometriosis remain incompletely understood, a cohort of endometriosis patients will be also studied. The overarching objective is to uncover the underlying mechanisms that advance the comprehension of menstrual pain biology and establish these mechanisms as phenotypic markers for treating REL-CT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nIdiopathic pelvic pain (40 participants):\n\n* Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months.\n* Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis).\n\nEndometriosis (20 participants)\n\n* Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past\n* Previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission.\n\nExclusion Criteria:\n\n* History of blood clots,\n* Allergies to REL-CT ingredients\n* Diabetes\n* Migraines\n* Osteoporosis\n* Vascular disease\n* Hormone-sensitive cancers\n* Smoking.\n* Missing limbs\n* Paralysis,\n* Conditions associated with irregular menses\n* Congenital conditions affecting reproductive function\n* Intrauterine device use\n* Pelvic inflammatory conditions\n* Active genitourinary infections,\n* Inability to read or comprehend the informed consent document written in English\n* History of metallic implants, history of metallic injury, any condition precluding investigation with MRI\n* BMI exceeding 40\n* Uncontrolled thyroid dysfunction\n* Adrenal dysfunction\n* Renal disorders\n* Liver disorders\n* Coagulopathy,\n* Gastrointestinal conditions or surgeries that may affect absorption'}, 'identificationModule': {'nctId': 'NCT06279195', 'briefTitle': 'Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Endeavor Health'}, 'officialTitle': 'Comprehensive Mechanistic Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment', 'orgStudyIdInfo': {'id': 'EH23-326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Idiopathic Pelvic Pain', 'description': 'Participants with Idiopathic Pelvic Pain must: 1. Self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis). Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.', 'interventionNames': ['Drug: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Endometriosis:', 'description': 'Participants with Endometriosis: 1. Must self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Have a previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission. Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.', 'interventionNames': ['Drug: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet']}], 'interventions': [{'name': 'Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet', 'type': 'DRUG', 'otherNames': ['Myfembree', 'Relugolix Combination Therapy', 'REL-CT'], 'description': 'All participants will be instructed to take REL-CT.', 'armGroupLabels': ['Endometriosis:', 'Idiopathic Pelvic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '18 months.', 'ipdSharing': 'YES', 'description': 'We plan to share anonymized data with potentially interested experience scientific researchers. Shared data includes pain diary, questionnaire data, MRI data, and sensory testing data.', 'accessCriteria': 'Data obtained through this study may be provided to qualified researchers with academic interest in pelvic pain. Data or samples shared will be coded, with no personally identifying included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endeavor Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Kevin Hellman', 'investigatorAffiliation': 'Endeavor Health'}}}}