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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

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Conditions

Reproductive DisorderNeurodegenerationSARS-CoV 2Long COVID

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States