Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT05484167
Status:
WITHDRAWN
Last Update Posted:
2022-12-21
First Post:
2022-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natesto Testosterone Nasal Gel for Hypogonadal Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The patient crosses over at 90 days'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'They study lost funding and decided to close the study down.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-16', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.', 'timeFrame': 'At Baseline and at the end of the study (Day 180)', 'description': 'The primary endpoint of the study will be mean change in erectile function and satisfaction with sexual intercourse using the validated SHIM questionnaire. This questionnaire has been used extensively in clinical trials evaluating PDE5i for ED and is also used very commonly in the clinical practice. The SHIM Is a 5 item questionnaire that assesses the ability to get and maintain an erection sufficient for intercourse (Q1-Q4) and Q5 which assesses patient satisfaction. Each question is scored 0 to 5 with a total maximum score of 25.\n\nThe investigators will look at the answers to all 5 questions and a higher score is interpreted as a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Sexual Function Scores Recorded at Baseline and End of Study', 'timeFrame': 'At Baseline and at the end of the study (Day 180)', 'description': "Secondary outcomes will include a comparison of answers to question #2 in the Sexual Encounter Profile (SEP): Was the participant able to insert the penis into the partner's vagina? This is a question asked at baseline and at the end of the study. Answers are recorded as Yes or No and Yes is interpreted as a better outcome."}, {'measure': 'Comparison of Erection Success Recorded at Baseline and End of Study', 'timeFrame': 'At Baseline and at the end of the study (Day 180)', 'description': "Secondary outcomes will include a comparison of answers to question #3 in the Sexual Encounter Profile (SEP): Did the participant's erection last long enough to have successful intercourse? This is a question that will be asked at baseline and at the end of the study. Answers are recorded as Yes or No and Yes is interpreted as a better outcome."}, {'measure': 'Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study', 'timeFrame': 'At Baseline and at the end of the study (Day 180)', 'description': 'Secondary outcomes will include a comparison of the total score for the Treatment Satisfaction Questionnaire for Medication (TSQM-9) at baseline and again at the end of the study.\n\nThe TSQM-9 scale is descriptive in nature and includes the following scales such as:\n\n1. Very satisfied\n2. Somewhat satisfied\n3. Neither satisfied nor dissatisfied\n4. Somewhat dissatisfied\n5. Very dissatisfied\n\nHigher scores are considered as a better outcome.'}, {'measure': 'Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study', 'timeFrame': 'Baseline and at the end of the study (Day 180)', 'description': 'Secondary outcomes will include a comparison of the total score for the Change in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) at baseline and again at the end of the study. The EDITS scale is descriptive in nature and includes the following scales such as:\n\n1. Very satisfied\n2. Somewhat satisfied\n3. Neither satisfied nor dissatisfied\n4. Somewhat dissatisfied\n5. Very dissatisfied\n\nHigher scores are considered as a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.', 'detailedDescription': 'The purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The study involves a diagnosis of Erectile Dysfunction. Therefore, all patients must have a penis, and this diagnosis.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to understand and provide written informed consent for the study.\n* Ability to read and complete electronic questionnaires in English.\n* Adult males between the ages of 18-64 years\n* Mild-moderate ED based on SHIM score between 8-21 at study entry\n* Ability to take daily Tadalafil\n* Ability to undergo venipuncture\n* Ability to provide ejaculated semen sample\n* Stable female sexual partner with sexual activity at least 1-3 times/month\n* Hypogonadism defined as two (one done as SOC within the last 6 months and one done at the time of screening) early morning total testosterone lab values \\<300\n\nExclusion Criteria:\n\n* Morbid Obesity - BMI \\>35\n* History of Diabetes (HBA1c \\>6.0)\n* Hematocrit \\< 35% or \\> 54% at study entry\n* Concurrent or Prior use of other exogenous testosterone or hormone therapy (SERM, aromatase inhibitor, gonadotropins) within the last 3 months.\n* Concurrent use of other prescription medications for ED including PDE5 inhibitors, intracavernosal injection therapy, urethral suppositories\n* Concurrent use of nitrates in any form\n* History of pelvic radiation\n* Spinal cord injury\n* Any progressive neurologic disease (Alzheimer's, Parkinson's, multiple sclerosis, etc).\n* History of penile prosthesis\n* History of prostatectomy\n* History of transurethral resection of prostate\n* History of stroke or myocardial infarction within the past 6 months\n* History of congestive heart failure\n* History of untreated obstructive sleep apnea\n* History of liver disease (Serum transaminases \\> 2.5 times upper limit of normal)\n* History of chronic kidney disease (GFR\\<60 or Serum Cr \\>2)\n* History of, current or suspected, prostate (abnormal DRE or elevated PSA \\>4.0) or breast cancer.\n* History of azoospermia or oligospermia (\\<15 million/ml)\n* History of vasectomy\n* History of Priapism\n* History of Polycythemia Vera\n* Receipt of any investigational product within 4 weeks of study enrollment\n* Recurrent upper respiratory or sinus infection (\\>3 times/month for \\>6 months)\n* Recurrent epistaxis (\\>3 times/month for \\>6 months)"}, 'identificationModule': {'nctId': 'NCT05484167', 'briefTitle': 'Natesto Testosterone Nasal Gel for Hypogonadal Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor', 'orgStudyIdInfo': {'id': '00144770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Natesto', 'description': 'Natesto™ is a testosterone nasal gel that is FDA approved to treat low testosterone. It delivers testosterone through the nasal passages and it is then absorbed into the blood stream. The nasal pump is placed at the opening of each nostril and then the participant would press down on the nasal pump to apply the gel. Each application takes about 10 seconds and the nasal pump applies a thin layer of gel that absorbs through the lining of the nose.', 'interventionNames': ['Drug: Natesto Nasal Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This study involves a placebo. The placebo will look like the Natesto™ nasal pump and will contain a nasal gel, but without any active ingredients.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Natesto Nasal Product', 'type': 'DRUG', 'otherNames': ['Natesto Nasal Gel'], 'description': 'Nasal Gel used for 90 days then crossed over to placebo gel', 'armGroupLabels': ['Natesto']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A nasal gel with no active ingredients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, Division of Urology', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'James Hotaling, MS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah, Division of Urology, Department of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acerus Pharmaceuticals Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jim Hotaling', 'investigatorAffiliation': 'University of Utah'}}}}