Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT00329693
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046650', 'term': 'quinagolide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2006-05-23', 'studyFirstSubmitQcDate': '2006-05-24', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OHSS', 'timeFrame': '41 days after hCG injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ovarian Hyperstimulation Syndrome']}, 'referencesModule': {'references': [{'pmid': '33851429', 'type': 'DERIVED', 'citation': 'Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.'}, {'pmid': '20139430', 'type': 'DERIVED', 'citation': 'Busso C, Fernandez-Sanchez M, Garcia-Velasco JA, Landeras J, Ballesteros A, Munoz E, Gonzalez S, Simon C, Arce JC, Pellicer A. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial. Hum Reprod. 2010 Apr;25(4):995-1004. doi: 10.1093/humrep/deq005. Epub 2010 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.', 'detailedDescription': 'No data to be entered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Signed Informed Consent Form, prior to screening evaluations\n2. In good physical and mental health\n3. Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation\n4. Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility\n\nExclusion Criteria\n\n1. Any clinically significant systemic disease\n2. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)\n3. History of recurrent miscarriage\n4. Undiagnosed vaginal bleeding'}, 'identificationModule': {'nctId': 'NCT00329693', 'briefTitle': 'Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.', 'orgStudyIdInfo': {'id': 'FE999051 CS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Daily Tablets Dosing', 'interventionNames': ['Drug: Norprolac']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Daily Tablets Dose', 'interventionNames': ['Drug: Norprolac']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Daily Tablets Dosing', 'interventionNames': ['Drug: Norprolac']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Daily Tablets Dosing', 'interventionNames': ['Drug: Norprolac']}], 'interventions': [{'name': 'Norprolac', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['1']}, {'name': 'Norprolac', 'type': 'DRUG', 'description': 'Quinagolide', 'armGroupLabels': ['2']}, {'name': 'Norprolac', 'type': 'DRUG', 'description': 'Quinagolide', 'armGroupLabels': ['3']}, {'name': 'Norprolac', 'type': 'DRUG', 'description': 'Quinagolide', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'IVI Barcelona, Ronda General Mitre, 14', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48940', 'city': 'Leioa-Bizkaia', 'country': 'Spain', 'facility': 'IVI Bilbao, Paseo Landabarri, 1'}, {'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'IVI Madrid, Santiago de Compostela, 88', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30007', 'city': 'Murcia', 'country': 'Spain', 'facility': 'IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '41011', 'city': 'Seville', 'country': 'Spain', 'facility': 'IVI Sevilla, Avda. República Argentina, 58', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'IVI Valencia, Plaza de la Policía Local, 3', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '36203', 'city': 'Vigo (Pontevedra)', 'country': 'Spain', 'facility': 'IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}