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Purpose

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. This study will utilize the technique of frequent blood sampling (q10 minutes) to provide detailed neuroendocrine characterization of endogenous LH secretion before and after kisspeptin administration. This frequency of blood sampling is required to define the features of LH pulses.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female (ages 18-45 years) or Male (ages 18-60 years) - Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg) - Hemoglobin no less than 0.5 g/dL below the lower limit of the sex specific reference range - 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 - Excessive alcohol consumption (>10 drinks/week) - Active use of illicit drugs - For women, - Pregnant - Trying to become pregnant during protocol participation - Breast feeding - History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Kisspeptin administration 		Single bolus of kisspeptin
  • Drug: Kisspeptin 112-121
    Single bolus of kisspeptin
    Other names:
    • Metastin 45-54

Recruiting Locations

More Details

NCT ID
NCT07224490
Status
Not yet recruiting
Sponsor
Stephanie B. Seminara, MD

Study Contact

Study Coordinator
617-643-2308
MGHKisspeptinResearch@partners.org

Detailed Description

Delivery of Interventions: - 1-2 hours of q10 minute blood sampling - Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.