TrialPath
Recruiting

Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

NCT07224490 · Massachusetts General Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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
Eligibility criteria
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
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: adult
Timeline
Starts: 2026-03-10
Estimated completion: 2030-05
Last updated: 2026-05-19
Interventions
Drug: Kisspeptin 112-121
Primary outcomes
  • Difference in mean luteinizing hormone (LH) amplitude between cases and controls (Day of study visit (one to two hours))
Sponsor
Stephanie B. Seminara, MD · other
With: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contacts & investigators
ContactStudy Coordinator · contact · MGHKisspeptinResearch@partners.org · 617-643-2308
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease · TrialPath