NCT07224490 · Stephanie B. Seminara, MD
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
What this study is about
The objective of this protocol is to use a case-control paradigm to compare the response to an given through a vein (IV) administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations