Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

Stephanie B. Seminara, MD

Status and phase

Not yet enrolling

Phase 1

Conditions

SARS-CoV 2

Neurodegeneration

Reproductive Disorder

Treatments

Drug: Kisspeptin 112-121

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07224490

R37HD043341 (U.S. NIH Grant/Contract)

565179

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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