Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01753102
Status:
TERMINATED
Last Update Posted:
2018-10-09
First Post:
2012-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-06', 'studyFirstSubmitDate': '2012-12-15', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal pH', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Symptoms of vulvar and vaginal atrophy', 'timeFrame': '14 days', 'description': 'Each subject will specify identified most bothersome symptoms vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity, vaginal bleeding associated with sexual activity) and self-evaluate the symptom on a pre-defined scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Estradiol', 'Vulvar atrophy', 'vaginal atrophy'], 'conditions': ['Vulvar Atrophy', 'Vaginal Atrophy']}, 'descriptionModule': {'briefSummary': "Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.\n\nThe estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.\n\nThe purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.", 'detailedDescription': 'Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.\n\nThis is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.\n\nThe patients will be administered with one tablet intravaginally daily for 14 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal woman\n* At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy\n* ≤ 5% superficial cells on vaginal smear cytology\n* Vaginal pH \\> 5.0\n\nExclusion Criteria:\n\n* Consumption of estrogen alone or estrogen/progestin containing drug products.\n* Allergy to estradiol or related products\n* History of breast cancer and significant risk factors for endometrial cancer\n* Abnormal genital bleeding'}, 'identificationModule': {'nctId': 'NCT01753102', 'briefTitle': "Efficacy and Safety Of Spil's Estradiol Vaginal Tablet", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': "EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY", 'orgStudyIdInfo': {'id': 'CLR_10_19'}, 'secondaryIdInfos': [{'id': 'CTRI/2012/09/002983', 'type': 'OTHER', 'domain': 'DCGI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol', 'description': 'Intravaginal self-administration of study medication once daily for 14 days.', 'interventionNames': ['Drug: Estradiol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference: Estradiol', 'description': 'Intravaginal self-administration of study medication once daily for 14 days.', 'interventionNames': ['Drug: Estradiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intravaginal self-administration of study medication once daily for 14 days.', 'interventionNames': ['Drug: Estradiol']}], 'interventions': [{'name': 'Estradiol', 'type': 'DRUG', 'otherNames': ['Vagifem'], 'description': 'one tablet will be inserted daily for 14 days', 'armGroupLabels': ['Estradiol', 'Placebo', 'Reference: Estradiol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Biniwale Clinic Pvt. Ltd,', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}