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

NCT02937740 | Completed Phase 4 Results

• 1 other identifier: NAT-2016-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 11

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.

Conditions

Hypogonadism

Keywords

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction - Change From Baseline

  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.

  Baseline and 3 months for BID, 4 months for TID

Secondary Outcomes (3)

• Change in Hypogonadism Symptoms

  Baseline and 3 months for BID, 4 months for TID

• Patient Treatment Preference Versus Prior Testosterone Replacement Therapy

  Last visit, i.e. 3 months for BID, 4 months for TID

• Frequency of Daily Dose of NATESTO by the End of the Study

  3 months for those who remained on BID, 4 months for those uptitrated to TID

Study Arms (2)

Naive patients - ARM 1

OTHER

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

Non-naive patients - ARM 2

OTHER

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

Interventions

NATESTO Testosterone Nasal Gel DRUG

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.

Also known as: NATESTO

Naive patients - ARM 1; Non-naive patients - ARM 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acerus Pharmaceuticals Corporation: lead

Study Sites (11)

Prostate Cancer Centre - Research

Calgary, Alberta, T2V 1P9, Canada

Location

Silverado Research Inc.

Victoria, British Columbia, V8T 2C1, Canada

Location

LMC Barrie

Barrie, Ontario, L4M 7G1, Canada

Location

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, L7N 3V2, Canada

Location

Lawson Research Institute / St Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

The Fe/Male Health Centre

Oakville, Ontario, L6H 3P1, Canada

Location

Toronto Urology Clinical Study Group

Toronto, Ontario, M6A 3B5, Canada

Location

Rabih Nour Clinic Windsor

Windsor, Ontario, N8X 3V6, Canada

Location

Ultra-Med Inc.

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Clinique D'Andropause de Quebec

Québec, Quebec, G1H 6P3, Canada

Location

Dr. Carlos Marois Urologue

Verdun, Quebec, H4G 1E2, Canada

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Natesto

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Nathan Bryson, Chief Scientific Officer
• Organization: Acerus Pharmaceuticals Corporation

nbryson@aceruspharma.com

1-416-679-0776

Study Officials

• Nathan Bryson, Ph.D.

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)