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NCT Number: NCT07224490

Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

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.

Recruiting

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kisspeptin 112-121

Drug

Single bolus of kisspeptin

Other names: Metastin 45-54

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

617-643-2308

Sponsors and collaborators

Lead sponsor

Stephanie B. Seminara, MD

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 4, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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