Recruiting
Phase 1

Kisspeptin

Sponsor:

Stephanie B. Seminara, MD

Code:

NCT07224490

Conditions

Reproductive Disorder

Neurodegeneration

SARS-CoV 2

Long COVID

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Kisspeptin 112-121

Study Details

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.

Conditions

Reproductive Disorder

Neurodegeneration

SARS-CoV 2

Long COVID

Study ID

NCT07224490

Start date

Mar 10, 2026

Status verified date

Jul, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Kisspeptin administration

Single bolus of kisspeptin

Interventions

Kisspeptin 112-121

Single bolus of kisspeptin

Primary outcome measure

  • Difference in mean luteinizing hormone (LH) amplitude between cases and controls [ Time Frame: Day of study visit (one to two hours) ]

Central Contacts and Locations

Central contacts

Study Coordinator

617-643-2308MGHKisspeptinResearch@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

617-643-2308MGHKisspeptinResearch@partners.org

More Information

Sponsor

Stephanie B. Seminara, MD

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephanie B. Seminara, MD on 2026-07-13.