Natesto Spermatogenesis Reboot

NCT05381831 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: IRB202102979OCR41644
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-blinded study of hypogonadal men with a history of testosterone therapy who became azoospermic or severely oligospermic and wish to avoid symptoms of hypogonadism during their recovery of spermatogenesis in an effort to establish paternity. The study will determine if Natesto can alleviate hypogonadal symptoms while preserving the recovery of spermatogenesis

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

• Changes in total motile sperm count

  Change in sperm count will be analyzed using the ANOVA. A change in \< ± 10% will be reject the null hypothesis.

  Baseline up to 26 weeks

Study Arms (1)

NatestoTM

EXPERIMENTAL

Participants in this group will receive Natesto for a 26 consecutive weeks treatment course

Drug: NatestoTM

Interventions

NatestoTM DRUG

Administering daily intranasal testosterone, Natesto nasal gel is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone

NatestoTM

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: The condition only affects males
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male between 18 and 64 years of age, 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 greater than 19 points.
• Body mass index (BMI) equal to or greater than or equal to 40 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 greater than 16 g/dL
• Hematocrit less than 35% or greater than 50%
• PSA greater than 4 ng/mL and age greater than 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

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Eunuchism

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Kevin Campbell, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2022
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)