Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
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- STATUS
- Recruiting
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- End date
- Feb 28, 2025
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- participants needed
- 24
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- sponsor
- Stephanie B. Seminara, MD
Summary
The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
Description
- Assignment: Each study subject will serve as their own control. The order of kisspeptin
doses will be randomized within each set/exposure.
- Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
- On the day of the inpatient study, the subjects will
- Undergo q10 min blood sampling for 6 hours,
- Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
- Undergo q10 min blood samplings for another 6 hours,
- Receive a single GnRH IV bolus at hour 51.
Details
| Condition | Hypogonadotropic Hypogonadism |
|---|---|
| Treatment | kisspeptin 112-121, GnRH |
| Clinical Study Identifier | NCT04648969 |
| Sponsor | Stephanie B. Seminara, MD |
| Last Modified on | 4 October 2022 |
Eligibility
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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