Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03459833
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061686', 'term': 'Premature Ejaculation'}], 'ancestors': [{'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-10', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-03-03', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IELT', 'timeFrame': 'Change from baseline after one month', 'description': 'Intra-vaginal Ejaculation Latency Time'}, {'measure': 'AIPE', 'timeFrame': 'Change from baseline after one month', 'description': 'Arabic index of premature ejaculation'}], 'secondaryOutcomes': [{'measure': 'IELT', 'timeFrame': 'Change from baseline after three, six and nine months', 'description': 'Intra-vaginal Ejaculation Latency Time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premature ejaculation', 'IELT', 'hyaluronic acid', 'glans penis augmentation'], 'conditions': ['Premature Ejaculation']}, 'descriptionModule': {'briefSummary': 'This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy\n\nExclusion Criteria:\n\n* Erectile dysfunction\n* Hypo or hyperthyroidism\n* Hypogonadism\n* Hyperprolactinemia\n* Drug abuse\n* Psychiatric disorders or related medications'}, 'identificationModule': {'nctId': 'NCT03459833', 'briefTitle': 'Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial', 'orgStudyIdInfo': {'id': 'PE:HA glans augmentation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': '15 patients They will receive a topical anesthetic agent for 30 minutes (Emla cream; lidocaine 25 mg, prilocaine 25 mg, Astra Xeneca, Mississauga, Canada) followed by injection of two prefilled 1 ml syringes with 30 G needle of hyaluronic acid (HA; Teosyal® PureSense Global Action, Teoxane Laboratories, Geneva, Switzerland). After 18 months from the HA injection, cross-over to placebo arm will be done.', 'interventionNames': ['Drug: Hyaluronic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group 2', 'description': 'They receive by the same method 2 ml saline as a placebo. After one month of the injection, cross-over to HA arm will be done.', 'interventionNames': ['Drug: Hyaluronic Acid']}], 'interventions': [{'name': 'Hyaluronic Acid', 'type': 'DRUG', 'description': 'Glans penis augmentation using multiple puncture technique as described by Abdallah et al. (2012) with minor modifications. HA is injected at two circular levels: one at the level of corona of glans penis and a second circular level is mid-way between the corona and urethral meatus. Six injections are injected at coronal level and four are injected in the second level, each injection is of 0.2 ml and is injected into deep dermis.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hamed A Hamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Andrology, Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical demonstrator', 'investigatorFullName': 'Mohamed Wael Ragab', 'investigatorAffiliation': 'Cairo University'}}}}