A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    218
  • sponsor
    Acerus Pharmaceuticals Corporation
Updated on 29 October 2021
replacement therapy
testosterone
testosterone level
antihypertensive
testosterone gel

Summary

The purpose of this study is to assess the change in 24-hour ambulatory blood pressure monitoring (ABPM) between baseline (Day 0) and Day 120 following 4 months of testosterone therapy with Natesto.

Details
Condition Hypogonadism
Treatment Natesto, Natesto
Clinical Study IdentifierNCT04976595
SponsorAcerus Pharmaceuticals Corporation
Last Modified on29 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures
Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65
Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples obtained no greater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy if not testosterone naive. Historical values from the past 6 months may be used
Testosterone Therapy naive, OR off any testosterone therapy for at least 4 months OR agree to a 4-month washout of current testosterone therapy prior to entry at Visit 1
Average office blood pressure measurement <140 millimetre of mercury (mmHg) SBP -AND- <90 mmHg DBP
If the participant is on an antihypertensive regimen, he has been on it for at least 4 weeks
Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG)

Exclusion Criteria

History of significant sensitivity or allergy to androgens, castor oil or product excipients
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, an abnormal ECG
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points
Body mass index (BMI) 35 kg/m^2
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to
Prostate specific antigen (PSA) > 4 ng/mL
Hematocrit < 35% or > 50%
Baseline hemoglobin > 16 g/dL
Hemoglobin A1C (HbA1C) > 9.0%
Estimated glomerular filtration rate (eGFR) <45
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures
History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration except for diabetes, or renal disease
History of stroke or myocardial infarction within the past 5 years
History of, or current or suspected, prostate or breast cancer
History of diagnosed, severe, untreated, obstructive sleep apnea
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years
Currently using tobacco, e-cigarettes or other nicotine containing products
History of nasal disorders such as nasal surgery; nasal trauma resulting in nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum; or sinus surgery or sinus disease
Receipt of any investigational product within 4 weeks of study start
Inability to understand and provide written informed consent for the study
Considered by the investigator or the sponsor-designated physician, for any reason, as an unsuitable candidate to receive Natesto
Participants working night-shifts
Participants performing strenuous manual labor while wearing the ABPM monitor
Participants with chronic atrial fibrillation (interferes with the ability to obtain precise ambulatory recordings)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note