Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ (MyT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937740
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation

Brief Summary:
Multicenter study consisting of two study periods as follows: a 90-day Treatment Period, with potential extension by 30 days for those patients requiring a dose increase, as determined by the treating physician. Participants receiving 122.5mg of NATESTO (5.5 mg of testosterone) per nostril twice daily may have an increased daily dose adjustment on Day 90, based on their hypogonadism symptoms.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: NATESTO Testosterone Nasal Gel Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 150-Day, Prospective, Phase 4, Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Testosterone Nasal Gel (Natesto™)
Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Naive patients - ARM 1

NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.

For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.

Drug: NATESTO Testosterone Nasal Gel

Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.

For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID dose), NATESTO will be administered intranasally once in the morning, once in the afternoon and once in the evening (approximately 6-8 hours apart), preferably at the same time each day for a total daily dose of 33 mg/day of testosterone.

Other Name: NATESTO

Non-naive patients - ARM 2

NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.

For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.

Drug: NATESTO Testosterone Nasal Gel

Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.

For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID dose), NATESTO will be administered intranasally once in the morning, once in the afternoon and once in the evening (approximately 6-8 hours apart), preferably at the same time each day for a total daily dose of 33 mg/day of testosterone.

Other Name: NATESTO




Primary Outcome Measures :
  1. Patient Satisfaction - Change From Baseline [ Time Frame: Baseline and 3 months for BID, 4 months for TID ]
    The primary objective of this study is to measure patient satisfaction with testosterone replacement therapy before, during and after treatment with NATESTO. Patient satisfaction with treatment will be measured by TSQM (Treatment Satisfaction Questionnaire for Medication) Version 9, a 9-item validated instrument. TSQM domains include - Effectiveness, Convenience, Global Satisfaction. The score for each domain is converted into a scale out of 100. Higher values imply a better outcome.


Secondary Outcome Measures :
  1. Change in Hypogonadism Symptoms [ Time Frame: Baseline and 3 months for BID, 4 months for TID ]
    Change in hypogonadism symptoms from baseline as measured by qADAM, a 10 point validated instrument. qADAM is a 10-item, patient-reported outcome measure used to evaluate the symptom severity of hypogonadism. Responses can range from 1 to 5 per question allowing for a minimum to maximum score range of 10 to 50. Higher values imply a better outcome.

  2. Patient Treatment Preference Versus Prior Testosterone Replacement Therapy [ Time Frame: Last visit, i.e. 3 months for BID, 4 months for TID ]
    Patient treatment preference versus prior testosterone replacement therapy measured by the Treatment Preference questionnaire.

  3. Frequency of Daily Dose of NATESTO by the End of the Study [ Time Frame: 3 months for those who remained on BID, 4 months for those uptitrated to TID ]
    Frequency of daily dosing, i.e. how many patients remained on BID vs how many were uptitrated to TID by the end of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypogonadal male between 18 and 65 years of age, inclusive;
  • Able to understand and provide signed informed consent;
  • Have documented total serum testosterone levels ≤300 ng/dL;
  • Are currently being treated with any form of a topical testosterone replacement therapy for at least three months, or are treatment-naive.

Exclusion Criteria:

  • In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;
  • History of pituitary or hypothalamic tumors or history of any malignancy (including breast and prostate cancers) excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery;
  • Prostatomegaly or history of abnormal PSA levels (>10.0 ng/mL). If PSA is >10 ng/mL, a recent negative biopsy must be documented (within the last 12 months);
  • History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically Sjogren's syndrome;
  • Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants;
  • History of severe adverse drug reactions to testosterone therapies;
  • History or current evidence of abuse of alcohol or any drug substance;
  • Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones;
  • Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within the previous 12 months;
  • Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;
  • Poor compliance history;
  • Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937740


Locations
Layout table for location information
Canada, Alberta
Prostate Cancer Centre - Research
Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
Silverado Research Inc.
Victoria, British Columbia, Canada, V8T 2C1
Canada, Ontario
LMC Barrie
Barrie, Ontario, Canada, L4M 7G1
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Lawson Research Institute / St Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
The Fe/Male Health Centre
Oakville, Ontario, Canada, L6H 3P1
Toronto Urology Clinical Study Group
Toronto, Ontario, Canada, M6A 3B5
Rabih Nour Clinic Windsor
Windsor, Ontario, Canada, N8X 3V6
Canada, Quebec
Ultra-Med Inc.
Pointe-Claire, Quebec, Canada, H9R 4S3
Clinique D'Andropause de Quebec
Quebec City, Quebec, Canada, G1H 6P3
Dr. Carlos Marois Urologue
Verdun, Quebec, Canada, H4G 1E2
Sponsors and Collaborators
Acerus Pharmaceuticals Corporation
Investigators
Layout table for investigator information
Study Director: Nathan Bryson, Ph.D. Sponsor GmbH
  Study Documents (Full-Text)

Documents provided by Acerus Pharmaceuticals Corporation:
Study Protocol  [PDF] February 13, 2018
Statistical Analysis Plan  [PDF] November 28, 2017


Layout table for additonal information
Responsible Party: Acerus Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02937740     History of Changes
Other Study ID Numbers: NAT-2016-01
First Posted: October 19, 2016    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Acerus Pharmaceuticals Corporation:
Hypogonadism
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents