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Could a brain hormone fix low sex hormones? small study hints at possibility

NCT ID NCT04648969

Knowledge-focused Sponsor: Stephanie B. Seminara, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This completed Phase 2 trial tested a natural hormone called kisspeptin in 18 adults with hypogonadotropic hypogonadism, a condition where the body doesn't produce enough sex hormones. Participants received different doses of kisspeptin to see how it affected hormone pulses. The goal was to explore whether kisspeptin could lead to new treatments for this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
kisspeptin
What this could lead to
If successful, this could point toward a new treatment option for people with hypogonadotropic hypogonadism, a condition causing low sex hormones.
What could go wrong
This is a small, early-phase study with only 18 participants, so results may not apply to everyone. The intervention is experimental and not yet proven as a standard therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

May 2019

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion/exclusion criteria: * Age 18 years and older, * Confirmed diagnosis of HH with * Low testosterone or estradiol, * Low or low-normal gonadotropin levels, * Thyroid stimulating hormone (TSH) and prolactin within the reference range, * Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI), * All other medical conditions stable and well controlled, * No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition, * No history of a medication reaction requiring emergency medical care, * No illicit drug use, * No excessive alcohol consumption (\<10 drinks/week), * Normal blood pressure (BP), (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg), * White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range, * Prolactin below 110% of the upper limit of the reference range, * Hemoglobin * Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women, * Men: on adequate testosterone replacement therapy: normal male reference range, * Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated, * For women, * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration), * Not breastfeeding and not pregnant.

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Conditions

The condition(s) this trial relates to.

hypogonadism hypogonadotropic hypogonadism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypogonadotropic hypogonadism

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.