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RECRUITING Phase 2

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

NCT07224438 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Interventions

  • DRUG kisspeptin 112-121

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-12-09
Est. Completion 2030-05
Phase Phase 2

Sponsor

Stephanie B. Seminara, MD

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07224438

The ClinicalTrials.gov registry entry for NCT07224438 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stephanie B. Seminara, MD, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 1 intervention — of which kisspeptin 112-121 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07224438 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07224438 about?

NCT07224438 is a clinical study titled "Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea". The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin ...

What is the current status of trial NCT07224438?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-12-09. Estimated completion is 2030-05.

What conditions does trial NCT07224438 study?

This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism, Hypothalamic Amenorrhea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07224438?

The interventions under investigation include: kisspeptin 112-121 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07224438?

This trial is sponsored by Stephanie B. Seminara, MD, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07224438 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial