Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02215434
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000279', 'term': 'Administration, Cutaneous'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone 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'}, {'id': 'D000287', 'term': 'Administration, Topical'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety of transdermal Testosterone Biolipid B2 effects', 'timeFrame': '12 weeks', 'description': 'Safety is assessed by comparing the rates of adverse events in the two treatment groups. Androgenic side effects including the frequency of facial depilation per month, hirsutism by the Ferriman-Gallwey scale (range 0-4 for each of nine body regions), acne by the Palatsi scale and clitoromegaly by examination were assessed at screening and the final visit.\n\nWe also monitor vital signs and concomitant medications.'}], 'primaryOutcomes': [{'measure': 'satisfactory sexual events', 'timeFrame': '12 weeks', 'description': 'Recent studies have reported an increase in the number of satisfactory sexual events (SSEs) recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.'}], 'secondaryOutcomes': [{'measure': 'Total testosterone and SHBG levels at screening and after 12 weeks of treatment.', 'timeFrame': '12 weeks', 'description': 'Total testosterone and SHBG levels were determined at screening and week 12.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Libido; Sexual Dysfunction; testosterone'], 'conditions': ['Sex Behavior']}, 'referencesModule': {'references': [{'pmid': '24519196', 'type': 'RESULT', 'citation': 'Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.'}], 'seeAlsoLinks': [{'url': 'http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322014000200075&lng=en&nrm=iso&tlng=en', 'label': 'Article'}]}, 'descriptionModule': {'briefSummary': 'Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.\n\nEfficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder (HSDD) in women has been demonstrated in studies including naturally and surgically menopausal women, either alone or in combination with estrogen, with or without progestin therapy.', 'detailedDescription': 'Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.\n\nThere is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido.\n\nTestosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment.\n\nTrials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants.\n\nWhether testosterone will benefit women with HSDD who are taking an antidepressant is not known.\n\nThe primary aim of this study was to examine the effects of transdermal testosterone therapy with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing treatment-emergent low libido. The primary study outcome was the change in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS).\n\nIn line with previous studies of women without depression, efficacy was measured by the change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general well-being, depression, and mood status.\n\nIn this present study these factors will be analized in 12 weeks interval'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a body mass index between 18 and 35 kg/m2\n* diminished libido complaints\n* no evidence of severe clinical depression\n* participants in good health based on history and physical examination.\n\nExclusion Criteria:\n\n* a past history of neurological disorder\n* recent psychiatric or systemic illness\n* use of psychoactive medications\n* alcohol excess consumption or any other drug abuse.\n* women who had under gone treatment for cardiovascular disease, genital bleeding, acne, depression, dyspareunia or those who had received oral androgen therapy in the previous 3 months were excluded\n* in addition women taking medications known to interfere with sex steroid metabolism were also excluded.'}, 'identificationModule': {'nctId': 'NCT02215434', 'acronym': 'TESTOSTERONE', 'briefTitle': 'Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University Potiguar'}, 'officialTitle': 'Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women', 'orgStudyIdInfo': {'id': 'UNP/CNPq02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Biolipid B2 (blanked/placebo)', 'description': 'The study is a single-center, single-blind, placebo-controlled, parallel group trial.\n\nIt consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination.\n\nThey were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL.\n\nThe testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks.', 'interventionNames': ['Drug: Biolipid B2 (blanked/placebo)', 'Drug: Testosterone, Transdermal, Behavior']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone, Transdermal, Behavior', 'description': 'Testosterone 0.5%, daily, 3 months', 'interventionNames': ['Drug: Biolipid B2 (blanked/placebo)', 'Drug: Testosterone, Transdermal, Behavior']}], 'interventions': [{'name': 'Biolipid B2 (blanked/placebo)', 'type': 'DRUG', 'otherNames': ['Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil', 'Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil'], 'description': 'the intervention will be the comparison effects of both emulsions', 'armGroupLabels': ['Biolipid B2 (blanked/placebo)', 'Testosterone, Transdermal, Behavior']}, {'name': 'Testosterone, Transdermal, Behavior', 'type': 'DRUG', 'otherNames': ['Transdermal testosterone Biolipid/B2'], 'description': 'Transdermal 0.5% testosterone Biolipid/B2', 'armGroupLabels': ['Biolipid B2 (blanked/placebo)', 'Testosterone, Transdermal, Behavior']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59060', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'University Potiguar', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}], 'overallOfficials': [{'name': 'MARCO A BOTELHO, M.Sc., Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Potiguar'}, {'name': 'Dinalva B Queiroz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Potiguar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Potiguar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Federal do Ceara', 'class': 'OTHER'}, {'name': 'Federal Institute of Science and Technology of Ceara', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}