Alabama Clinical Therapeutics | Birmingham, AL
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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.
Enrollment
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Inclusion criteria
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:
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).
Primary purpose
Allocation
Interventional model
Masking
218 participants in 1 patient group
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Central trial contact
Dr. C. Sorli Chief Medical Officer
Data sourced from clinicaltrials.gov
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