Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a natural hormone restore ovulation in women with hypothalamic amenorrhea?

NCT ID NCT05633966

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested whether a naturally occurring hormone called kisspeptin can stimulate reproductive hormones and help women with hypothalamic amenorrhea (a condition where periods stop due to low hormone levels) release eggs. Thirteen women received pulsatile injections of kisspeptin under the skin for two weeks. Researchers monitored egg development with ultrasound and measured hormone levels through frequent blood draws to see if the treatment could trigger ovulation.

What this could mean

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

Active substance
kisspeptin (a naturally occurring hormone)
What this could lead to
If it works, this could point toward a new treatment for women with hypothalamic amenorrhea to help them ovulate without traditional hormone therapies.
What could go wrong
This is a very small, early Phase 1 trial with only 13 participants. It is designed to test safety and basic effects, not to prove effectiveness. The results may not apply to all women with reproductive disorders.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Dec 2022

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 to 45 years

Sex

Female participants only

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 Criteria: * Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea) • Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins\] * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg) * Laboratory Studies: * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women * Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration) * No current or recent use of a medication 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 method of administration 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) and/or active use of illicit drugs • Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. * Pregnant or trying to become pregnant * Breast feeding * History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypogonadotropic hypogonadism are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

functional hypothalamic amenorrhea hypogonadism hypogonadotropic hypogonadism

As listed by the trial registrant

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

Hypogonadotropic hypogonadism Hypothalamic amenorrhea

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.