Hypogonadotropic HypogonadismPhase 1NCT04975334
Opioid Antagonism in Hypogonadotropic Hypogonadism
A Phase 1 study testing Naloxone in people with Hypogonadotropic Hypogonadism and Low Testosterone, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism, Low Testosterone
- What is being tested?
- Naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 26 Sep 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age 18-75 years
- Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
- All medical conditions stable
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- Negative urine drug screening panel
Show all 9Show fewer
- Hemoglobin
- Men on adequate testosterone replacement therapy: normal male reference range
- Men off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women
Who cannot join
- Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
- Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
- Current or recent use of a medication that affects the opioid pathway
- Active illicit drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
Read the detailed description
Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
- During the study, the subjects will undergo the following:
- Undergo q10 min blood sampling for 3 hours
- Receive a naloxone bolus at the midpoint of q10 min sampling
- Conditions
- Hypogonadotropic Hypogonadism, Low Testosterone
- Being tested
- Naloxone
- Keywords
- Hypogonadotropic Hypogonadism, naloxone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
One bolus of naloxone
| Study group | Role | What they receive |
|---|---|---|
| naloxone | Experimental | one period of frequent blood sampling with IV administration of naloxone (one bolus) Receives: Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Mean Luteinizing Hormone (LH) Value
Change in mean LH before vs. after naloxone bolus
Measured: Before and after treatment, a 3 hour period on a single study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start18 Jun 2025
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Stephanie Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975334
- Sponsor's protocol ID
- 313510
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2021
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Antagonism in Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT04975334
- Acronym / sponsor ID
- 313510
- Conditions
- Hypogonadotropic Hypogonadism, Low Testosterone
- Keywords
- Hypogonadotropic Hypogonadism, naloxone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
Detailed description
Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
- During the study, the subjects will undergo the following:
- Undergo q10 min blood sampling for 3 hours
- Receive a naloxone bolus at the midpoint of q10 min sampling
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| naloxone | Experimental | Drug: Naloxoneone period of frequent blood sampling with IV administration of naloxone (one bolus) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male
- Age 18-75 years
- Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
- All medical conditions stable
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
Key exclusion criteria (4 listed)
- Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
- Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
- Current or recent use of a medication that affects the opioid pathway
- Active illicit drug use
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 |
|---|---|---|
| NaloxoneOne bolus of naloxone | Drug | naloxone |
Primary outcome
Average Change in Mean Luteinizing Hormone (LH) Value
Time frame: Before and after treatment, a 3 hour period on a single study day
Change in mean LH before vs. after naloxone bolus
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hypogonadotropic Hypogonadism
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
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.
Stephanie Seminara, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naloxone in people with Hypogonadotropic Hypogonadism and Low Testosterone, run by Stephanie B. Seminara, MD 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 9 inclusion and 4 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 3 Jun 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Change in Mean Luteinizing Hormone (LH) Value (time frame: Before and after treatment, a 3 hour period on a single study day). 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 3 Jun 2026.