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NCT07224438 · ClinicalTrials.gov registry record · Phase 2

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

A Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea, sponsored by Stephanie B. Seminara, MD.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT07224438 is a Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea that is actively recruiting participants, run by Stephanie B. Seminara, MD. The registered enrollment target is 20 participants, below the 123-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07224438, a Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea, is actively recruiting participants, sponsored by Stephanie B. Seminara, MD.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

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

11 total trials

What the Registry Record Tells You About NCT07224438

The ClinicalTrials.gov registry entry for NCT07224438 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (84% lower). The listed sponsor is Stephanie B. Seminara, MD, which has 11 total studies on file at ClinicalTrials.gov.

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.

NCT07224438 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

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.

What interventions are being tested in trial NCT07224438?

The interventions under investigation include: kisspeptin 112-121 (DRUG).

Who is sponsoring clinical trial NCT07224438?

This trial is sponsored by Stephanie B. Seminara, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.

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.

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