Reproductive DisorderPhase 1NCT07224490
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
A Phase 1 study testing Kisspeptin 112-121 in people with Reproductive Disorder and Neurodegeneration, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reproductive Disorder, Neurodegeneration, SARS-CoV 2
- What is being tested?
- Kisspeptin 112-121
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to May 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female (ages 18-45 years) or Male (ages 18-60 years)
- No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
- For women, negative serum hCG pregnancy test
- For cases, diagnosis of post-covid-19 syndrome
- For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome
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 or the interpretation of results
- Active use of illicit drugs (not including marijuana)
- For women,
- Pregnant
- Trying to become pregnant during protocol participation
- Breast feeding
- Surgical or natural menopause
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Study Coordinator, 617-643-2308, MGHKisspeptinResearch@partners.org
About this study
The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.
Read the detailed description
Delivery of Interventions:
- Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg
- Blood sampling before and after administration of kisspeptin (two timepoints total)
- Conditions
- Reproductive Disorder, Neurodegeneration, SARS-CoV 2, Long COVID
- Being tested
- Kisspeptin 112-121
- Keywords
- Reproductive disorder, Neurodegeneration, SARS-CoV 2, Kisspeptin, Long COVID
- Medical subject headings
- Nerve Degeneration, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kisspeptin 112-121Drug
Also called Metastin 45-54
Single bolus of kisspeptin
| Study group | Role | What they receive |
|---|---|---|
| Kisspeptin administration | Experimental | Single bolus of kisspeptin Receives: Drug: Kisspeptin 112-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean luteinizing hormone (LH) amplitude between cases and controls
Difference between cases and controls of mean LH amplitude in response to kisspeptin
Measured: Day of study visit (one to two hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start10 Mar 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive DisorderStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224490
- Sponsor's protocol ID
- 565179
- Other IDs
- R37HD043341
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2025
- Last updated
- 13 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
- ClinicalTrials.gov ID
- NCT07224490
- Acronym / sponsor ID
- 565179
- Conditions
- Reproductive Disorder, Neurodegeneration, SARS-CoV 2, Long COVID
- Keywords
- Reproductive disorder, Neurodegeneration, SARS-CoV 2, Kisspeptin, Long COVID
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 4 Nov 2025 (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.
The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.
Detailed description
Delivery of Interventions:
- Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg
- Blood sampling before and after administration of kisspeptin (two timepoints total)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kisspeptin administration | Experimental | Drug: Kisspeptin 112-121Single bolus of kisspeptin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female (ages 18-45 years) or Male (ages 18-60 years)
- No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
- For women, negative serum hCG pregnancy test
- For cases, diagnosis of post-covid-19 syndrome
- For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome
Key exclusion criteria (7 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 or the interpretation of results
- Active use of illicit drugs (not including marijuana)
- For women,
- Pregnant
- Trying to become pregnant during protocol participation
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 |
|---|---|---|
| Kisspeptin 112-121Also: Metastin 45-54Single bolus of kisspeptin | Drug | Kisspeptin administration |
Primary outcome
Difference in mean luteinizing hormone (LH) amplitude between cases and controls
Time frame: Day of study visit (one to two hours)
Difference between cases and controls of mean LH amplitude in response to kisspeptin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
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 Kisspeptin 112-121 in people with Reproductive Disorder and Neurodegeneration, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (617-643-2308, MGHKisspeptinResearch@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean luteinizing hormone (LH) amplitude between cases and controls (time frame: Day of study visit (one to two hours)). 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 Jul 2026.