The Effects of Natesto For Treatment Of Hypogonadism

NCT04717362 | Withdrawn Early Phase 1

• 1 other identifier: 48763
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this prospective study, the investigators plan is to confirm the role of Natesto (intranasal testosterone) to combat hypogonadal symptoms in men trying to recover spermatogenesis following the withdrawal of conventional Testosterone replacement therapy.

Conditions

Hypogonadism, Male; Infertility, Male; Testosterone Deficiency

Keywords

Natesto; Male; Hypogonadism; Sexual Medicine

Outcome Measures

Primary Outcomes (1)

• Change in Semen Analysis

  Change in Total Motile Sperm

  Baseline, 14 weeks, 26 weeks.

Secondary Outcomes (7)

• Change in Hypogonadal Panel

  Baseline, 14 weeks, 26 weeks.

• Change in Hypogonadal Panel

  Baseline, 14 weeks, 26 weeks.

• Change Hypogonadal Panel

  Baseline, 14 weeks, 26 weeks.

• Change in Hypogonadal Panel

  Baseline, 14 weeks, 26 weeks.

• Change in Quality of Life Questionnaire

  Baseline, 14 weeks, 26 weeks.

Study Arms (1)

Standard Reboot with Natesto

EXPERIMENTAL

Standard Reboot Protocol + Natesto

Drug: Natesto Nasal Product

Interventions

Natesto Nasal Product DRUG

Nasally administered exogenous 4.5% testosterone gel, administered from a non-pressurized, manual pump dispenser equipped with a specialized nasal applicator which administers 125uL (5.5mg of testosterone).

Standard Reboot with Natesto

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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 64 years of age, inclusive, with documented onset of testosterone induced hypogonadism with impaired semen parameters who are attempting to achieve a successful pregnancy.
• \. Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
• \. Serum total testosterone \< 350 ng/dL based on 2 consecutive blood samples obtained 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy; with clinical symptoms of hypogonadism such as diminished energy and sexual function; and/or a decreased sperm count (\<20 million sperm/mL semen).
• \. Discontinued current testosterone replacement treatment and completed a washout of 4 weeks following androgen treatment (excluding Testopel TM). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.
• \. 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, and laboratory profile.

You may not qualify if:

• \. 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.
• \. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score \> 19 points.
• \. Body mass index (BMI) ≥ 35 kg/m2.
• \. History of vasectomy.
• \. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
• Baseline hemoglobin \> 16 g/dL
• Hematocrit \< 35% or \> 50%
• PSA \> 4 ng/mL and age \>40
• \. 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.
• \. 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

MeSH Terms

Conditions

Eunuchism; Infertility, Male; Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: rofessor of Urology and Chief of the Scott Department of Urology's Division of Male Reproductive Medicine and Surgery

Model Details: Prospective non-blinded study

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: January 22, 2021
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share