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Scientists hunt for genes behind puberty problems

NCT ID NCT01500447

Knowledge-focused Sponsor: National Institute of Environmental Health Sciences (NIEHS) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Updated 3 times

Summary

This study aims to understand how reproductive disorders, such as delayed or early puberty, are inherited. Researchers will collect blood samples and medical histories from 850 people with these conditions and their family members. No treatment is provided; the goal is to identify genetic variants linked to these disorders.

What this could mean

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

What this could lead to
If successful, this study could help identify genes linked to inherited reproductive disorders, paving the way for future treatments or diagnostic tests.
What could go wrong
This is an observational study, not a treatment trial. It may not directly benefit participants, and finding meaningful genetic links is uncertain.

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.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2012

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

Primary Clinical, self-referred or physician-referred subjects

Ages

6 weeks to 120 years

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 CRITERIA: The essential inclusion criteria include: 1. failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low/normal gonadotropins (due to substantial variability among patient presentations, this will be based on the clinical judgement of the Investigator), or 2. abnormally early development of puberty, or 3. normal puberty with subsequent development of low gonadotropin levels, or 4. individuals with features indicating an increased risk of hypogonadotropic hypogonadism. 5. Family members: both affected and unaffected family members are strongly encouraged to participate. EXCLUSION CRITERIA: Since hypogonadotropic hypogonadism is a rare condition, this protocol remains open to enrollment so that we may study all subjects that are both qualified and interested in participating. Because HH represents a spectrum, where associated clinical findings may provide phenotypic clues to the assessment of inheritability and underlying physiology, exclusion criteria are very limited: * Patients who have additional pituitary deficiencies, effectively ruling out isolated GnRH deficiency, whether these deficiencies are congenital or acquired (e.g. secondary to malignancy, infection, or irradiation). * Patients who are taking medications known to affect GnRH secretion, such as corticosteroids or continuous opiate administration (or were taking them at the time of diagnosis).

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Conditions

The condition(s) this trial relates to.

amenorrhea hereditary disease hypogonadism hypogonadotropic hypogonadism 7 with or without anosmia infertility disorder Kallmann syndrome precocious puberty Puberty, Delayed

As listed by the trial registrant

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

Amenorrhea Genetic disorder Hypogonadism Infertility

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NIEHS Clinical Research Unit (CRU)

    RECRUITING

    Research Triangle Park, North Carolina, 27713, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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