Hypogonadism, MalePhase 4NCT05381831
Natesto Spermatogenesis Reboot
A Phase 4 study testing NatestoTM in people with Hypogonadism, Male, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- NatestoTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 21 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 21Show fewer
- 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.
- History of nasal disorders such as nasal polyps; nasal septal perforation; nasal surgery; nasal trauma resulting in nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum; sinus surgery or sinus disease
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
- Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
- Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
- Inability to understand and provide written informed consent for the study.
- Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Natesto.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis
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
- Being tested
- NatestoTM
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatestoTMDrug
Administering daily intranasal testosterone, Natesto nasal gel is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone
| Study group | Role | What they receive |
|---|---|---|
| NatestoTM | Experimental | Participants in this group will receive Natesto for a 26 consecutive weeks treatment course Receives: Drug: NatestoTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Campbell, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381831
- Sponsor's protocol ID
- IRB202102979
- Other IDs
- OCR41644
- Status last verified
- Jun 2025
- First submitted
- 16 May 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis
- ClinicalTrials.gov ID
- NCT05381831
- Acronym / sponsor ID
- IRB202102979
- Conditions
- Hypogonadism, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NatestoTM | Experimental | Drug: NatestoTMParticipants in this group will receive Natesto for a 26 consecutive weeks treatment course |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatestoTMAdministering daily intranasal testosterone, Natesto nasal gel is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone | Drug | NatestoTM |
Primary outcome
Changes in total motile sperm count
Time frame: Baseline up to 26 weeks
Change in sperm count will be analyzed using the ANOVA. A change in < ± 10% will be reject the null hypothesis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Campbell, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NatestoTM in people with Hypogonadism, Male, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total motile sperm count (time frame: Baseline up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.