Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT01107093
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2010-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C094854', 'term': 'ulipristal'}, {'id': 'C555622', 'term': 'ulipristal acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhibition of follicular rupture', 'timeFrame': 'within 6 days after treatment intake', 'description': 'Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment'}], 'secondaryOutcomes': [{'measure': 'Appearance or absence of a corpus luteum', 'timeFrame': 'during the 6 days following treatment intake'}, {'measure': 'Growth pattern of leading follicle', 'description': 'number of cycles exhibiting atresia (diameter decrease ≥25%), or continued growth (diameter increase ≥25%), or interrupted growth (size remains within ±25% of the follicle size at the time of treatment)'}, {'measure': 'Presence or absence of a surge of serum luteinizing hormone (LH) levels', 'description': 'The onset of an LH surge is defined as the occurrence of the first single serum LH value whose level is at least 50% higher than the mean of the last two previous measurements, or higher than the last previous measurement if only one previous LH level is available.'}, {'measure': "Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length"}, {'measure': 'Incidence of intermenstrual bleeding and treatment-emergent adverse events'}, {'measure': 'Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline'}, {'measure': 'Incidence of ovarian cysts after CDB-2914 treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '20634186', 'type': 'RESULT', 'citation': 'Brache V, Cochon L, Jesam C, Maldonado R, Salvatierra AM, Levy DP, Gainer E, Croxatto HB. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010 Sep;25(9):2256-63. doi: 10.1093/humrep/deq157. Epub 2010 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:\n\n* echographic follicle rupture\n* inhibition of follicle rupture\n* luteal phase progesterone levels\n* anovulatory progesterone levels'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of good general health aged 18 - 35 years\n* Not at risk of pregnancy\n* Regular menstrual cycles of 24-35 days duration\n* Not pregnant\n* Intact uterus and ovaries\n* Haemoglobin ≥ 11 g/dl\n* Normal laboratory tests and normal TSH\n* Willing to abstain from any use of hormonal contraception until study completion\n* No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception\n* Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion\n* Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles\n\nExclusion Criteria:\n\n* Current participation in any other trial of an investigational medicine\n* Known hypersensitivity to the ingredients of the test active substances or excipients\n* Suspected hyperplasia or carcinoma of the endometrium\n* Current pregnancy as confirmed by positive serum beta-hCG at screening\n* Desire to get pregnant before the planned end of the study participation\n* Currently breastfeeding\n* Abnormal Pap smear\n* Cancer (past history of any carcinoma or sarcoma)\n* Known or suspected alcoholism or drug abuse\n* Abnormal thyroid status\n* Body mass index \\> 32\n* Current use of hormonal contraception\n* Use of hormonal emergency contraception since last menstrual period\n* Severe asthma insufficiently controlled by oral glucocorticoids\n* Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption'}, 'identificationModule': {'nctId': 'NCT01107093', 'briefTitle': 'Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge', 'organization': {'class': 'INDUSTRY', 'fullName': 'HRA Pharma'}, 'officialTitle': 'A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge', 'orgStudyIdInfo': {'id': '2914-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CDB-2914', 'interventionNames': ['Drug: CDB-2914 (ulipristal acetate)']}], 'interventions': [{'name': 'CDB-2914 (ulipristal acetate)', 'type': 'DRUG', 'description': 'single oral dose of 30 mg', 'armGroupLabels': ['CDB-2914']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'ICMER', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Clinica de PROFAMILIA', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HRA Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Erin Gainer, R&D Director', 'oldOrganization': 'HRA Pharma'}}}}