Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

NCT07224490 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 565179R37HD043341
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Reproductive Disorder; Neurodegeneration; SARS-CoV 2; Long COVID

Keywords

Reproductive disorder; Neurodegeneration; SARS-CoV 2; Kisspeptin; Long COVID

Outcome Measures

Primary Outcomes (1)

• Difference in mean luteinizing hormone (LH) amplitude between cases and controls

  Difference between cases and controls of mean LH amplitude in response to kisspeptin

  Day of study visit (one to two hours)

Study Arms (1)

Kisspeptin administration

EXPERIMENTAL

Single bolus of kisspeptin

Drug: Kisspeptin 112-121

Interventions

Kisspeptin 112-121 DRUG

Single bolus of kisspeptin

Also known as: Metastin 45-54

Kisspeptin administration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Nerve Degeneration; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes

Central Study Contacts

Study Coordinator

CONTACT

617-643-2308; MGHKisspeptinResearch@partners.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 4, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)