Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorStephanie B. Seminara, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Kisspeptin 112-121
DrugSingle bolus of kisspeptin
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Kisspeptin administrationExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Day of study visit (one to two hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stephanie B. Seminara, MD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov