Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT00640458
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the % of subjects who respond within 30 minutes of dosing by achieving an increase in clitoral engorgement >50% from baseline measured by MRI following audio/visual sexual stimulation in females with FSAD.', 'timeFrame': 'Up to 30 minutes post-dose'}], 'secondaryOutcomes': [{'measure': 'To determine the % of subjects who respond to sildenafil 100mg by achieving an increase in clitoral engorgement >50% from baseline within 40, 50 and 60 minutes of dosing respectively.', 'timeFrame': 'Up to 60 minutes post-dose'}, {'measure': 'To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings.', 'timeFrame': '30 days post-dose'}, {'measure': 'Assess plasma levels of sildenafil and metabolite', 'timeFrame': 'Day of dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Female Sexual Arousal Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481174&StudyName=Study%20to%20investigate%20effect%20of%20sildenafil%20on%20clitoral%20engorgement%20as%20measured%20by%20magnetic%20resonance%20imaging%20%28MRI%29%20in%20pre-menopausal%20wo', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia.\n\nExclusion Criteria:\n\n* Subjects with hypoactive sexual desire disorder.\n* Subjects not using an acceptable mean of contraception for the duration of the study.\n* Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.'}, 'identificationModule': {'nctId': 'NCT00640458', 'briefTitle': 'Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double Blind, Placebo Controlled 2-way Cross-over Study to Assess the Clitoral Engorgement Response as Measured by Non-contrast Magnetic Resonance Imaging (MRI) in Women With Female Sexual Arousal Disorder (FSAD) When Administered a Single Dose of Sildenafil (100mg) Followed by Audio/Visual Sexual Stimulation', 'orgStudyIdInfo': {'id': 'A1481174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Study Period 1 or 2', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Study Period 1 or 2', 'interventionNames': ['Drug: Sildenafil 100 mg']}], 'interventions': [{'name': 'Sildenafil 100 mg', 'type': 'DRUG', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195-6465', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}