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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 (Nat

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.

Detailed Summary:

The primary objective of the study is to measure patient satisfaction with testosterone replacement therapy before (for non-naïve patients), during and after treatment with NATESTO.

The secondary objectives of this study are to evaluate the following:

  • Improvement in hypogonadism symptoms;
  • Patient treatment preference versus prior testosterone replacement therapy;
  • Frequency of daily dose of NATESTO;
  • Safety monitoring.

The population for this study is adult men 18-65 years of age inclusive, with primary or secondary hypogonadism, with historical documented total serum testosterone concentration of ≤300 ng/dL and the ability to provide informed consent. Eligible subjects include treatment-naïve, hypogonadal patients with a documented confirmation of hypogonadism, as well as patients previously treated with an alternate topical testosterone replacement therapy (TRT) for at least three months prior to selection. Participants currently receiving topical testosterone replacement therapy will be required to discontinue their current testosterone treatment before initiating treatment with NATESTO. The approximate total duration of study participation for participants completing the study will be up to 150 days (~21 weeks).

This is a Phase 4, multicenter study consisting of two study periods as follows:

  • A 90-day Treatment Period, extended to 120-days for those subjects requiring a dose increase, during which participants will receive 122.5 mg of NATESTO (5.5mg testosterone) per nostril twice daily
    Sponsor: Acerus Pharmaceuticals Corporation

    Current Primary Outcome: Patient Satisfaction [ Time Frame: 3 months ]

    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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Improvement in hypogonadism symptoms [ Time Frame: 3-4 months ]
      Improvement in hypogonadism symptoms will be measured by the qADAM, a 10 point validated instrument.
    • Patient treatment preference versus prior testosterone replacement therapy [ Time Frame: 3-4 months ]
      Patient treatment preference versus prior testosterone replacement therapy will be measured by the Treatment Preference questionnaire. Mean item scores at Baseline and Day 90(BID)/Day 120(TID) for these instruments will be compared using ANOVA methods.
    • Frequency of daily dose of NATESTO [ Time Frame: 3-4 months ]
      Frequency of daily dosing with NATESTO will be summarized and descriptive statistics provided.


    Original Secondary Outcome: Same as current

    Information By: Acerus Pharmaceuticals Corporation

    Dates:
    Date Received: October 17, 2016
    Date Started: October 2016
    Date Completion: April 2017
    Last Updated: November 2, 2016
    Last Verified: November 2016