Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-21 @ 6:52 PM
Study NCT ID:
NCT01875718
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065446', 'term': 'Premenstrual Dysphoric Disorder'}], 'ancestors': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premenstrual symptom severity', 'timeFrame': 'Daily Record of Severity of Problems (DRSP) measured during 4-5 months'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'During 1.5 month (starting from first dose)'}]}, 'conditionsModule': {'conditions': ['Premenstrual Dysphoric Disorder']}, 'descriptionModule': {'briefSummary': "The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.\n\nIn part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart 1 -Essentially healthy\n\nPart 2 -Have PMDD according to DSM-IV verified in two menstrual cycles\n\nExclusion Criteria:\n\n* steroid hormonal treatment during the previous three months\n* treatment with psychopharmaceuticals or other treatment for PMS\n* history of or a significant medical condition ongoing\n* be pregnant or plan a pregnancy within the study period'}, 'identificationModule': {'nctId': 'NCT01875718', 'briefTitle': 'A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Umecrine Mood AB'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study', 'orgStudyIdInfo': {'id': 'UM104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UC1010 low dose', 'interventionNames': ['Drug: UC1010']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UC1010 high dose', 'interventionNames': ['Drug: UC1010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'UC1010', 'type': 'DRUG', 'armGroupLabels': ['UC1010 high dose', 'UC1010 low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17165', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Umecrine Mood AB', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umecrine Mood AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}