Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 8:06 AM
Study NCT ID:
NCT06605469
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ejaculatory and Orgasmic Dysfunction Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'id': 'D061686', 'term': 'Premature Ejaculation'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Objective', 'timeFrame': '3 years', 'description': 'Report subjective efficacy of therapies used to treat ejaculatory dysfunction. Study participants will have the option of indicating if they had used any treatments to treat ejaculatory disorders. If so, they will then be asked to measure its efficacy at improving their symptoms using a 1-10 scale (10 being very effective).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ejaculatory dysfunction', 'premature ejaculation', 'delayed ejaculation', 'anorgasmia', 'anejaculation', 'dysejaculation', 'dysorgasmia'], 'conditions': ['Ejaculatory Dysfunction', 'Premature Ejaculation', 'Delayed Ejaculation', 'Anorgasmia', 'Anejaculation', 'Dysejaculation', 'Dysorgasmia']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the safety and efficacy of various therapies used to treat ejaculatory and/or orgasmic dysfunctions in men. The objective is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction.\n\nParticipants will submit questionnaires about their diagnosis and treatment efficacy and multiple time intervals.', 'detailedDescription': 'The objective of the current study is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction. To accomplish this registry, CURE PD has partnered with the Sexual Medicine Society of North America (SMSNA) to help inform sexual medicine providers of the existence of the study and to help encourage patients to enroll.\n\nSubjects meeting criteria will be offered study entry by their local provider who will refer them to an email address to indicate their interest. Participants will then be administered questionnaires at baseline and every 3 months x 1 year, followed by every 6 months x 2 years. Patient partners will also be allowed to enroll and will receive questionnaires on the same schedule (baseline, q3 months x 1 year, q6 months x 2 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult men (\\>18) diagnosed with ejaculatory and/or orgasmic dysfunction who were recommended to begin any treatment for the condition\n\nFor partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men being treated for either ejaculatory and/or orgasmic dysfunction\n* For partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06605469', 'briefTitle': 'Ejaculatory and Orgasmic Dysfunction Registry', 'organization': {'class': 'OTHER', 'fullName': "Charitable Union for the Research and Education of Peyronie's Disease"}, 'officialTitle': 'Ejaculatory and Orgasmic Dysfunction Registry (Climax Registry)', 'orgStudyIdInfo': {'id': 'CUREPD200'}}, 'contactsLocationsModule': {'locations': [{'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Landon Trost, MD', 'role': 'CONTACT', 'email': 'email@mfp.clinic', 'phone': '888-655-0015'}, {'name': 'Holli Burgon', 'role': 'SUB_INVESTIGATOR'}], 'facility': "The Male Fertility and Peyronie's Clinic", 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Deidentified data will be made available to sites which have referred patients to the registry.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Charitable Union for the Research and Education of Peyronie's Disease", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}