NCT07224490PHASE1Recruiting
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
Stephanie B. Seminara, MD
Start Date
3/10/2026
Completion Date
5/1/2030
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.
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)
Eligibility Criteria
Age Range: 18 years to 60 years
Inclusion Criteria
* 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
Exclusion Criteria
* 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
Interventions
DRUG
Kisspeptin 112-121
Conditions
Reproductive DisorderNeurodegenerationSARS-CoV 2Long COVID
Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
United States