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

New drug shows promise for rare hormone disorder

NCT ID NCT03257462

Disease control Sponsor: Spruce Biosciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a new drug called SPR001 in 24 adults with classic congenital adrenal hyperplasia (CAH), a genetic condition that disrupts hormone production. The study aimed to see if SPR001 is safe and can improve hormone control. Participants took multiple doses of the drug, and researchers measured changes in key hormones like 17-hydroxyprogesterone. The results could point toward a better way to manage this lifelong condition.

What this could mean

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

Active substance
SPR001 capsules
What this could lead to
If successful, SPR001 could offer a new way to better control hormone levels in people with classic congenital adrenal hyperplasia, potentially reducing symptoms and the need for high-dose steroids.
What could go wrong
This is a small, early-phase trial with only 24 participants. The drug may not show enough benefit or could have side effects. More research is needed before it could become a treatment.

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

24 people

The number who actually took part.

Started

Jul 2017

Finished

Mar 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 Criteria: * Male and female patients age 18 or older. * Documented diagnosis of classic CAH due to 21-hydroxylase deficiency * Elevated 17-OHP at screening * On a stable glucocorticoid replacement regimen for a minimum of 30 days Exclusion Criteria: * Clinically significant unstable medical condition, illness, or chronic disease * Clinically significant psychiatric disorder. * Clinically significant abnormal laboratory finding or assessment * History of bilateral adrenalectomy or hypopituitarism * Pregnant or nursing females * Use of any other investigational drug within 30 days * Unable to understand and comply with the study procedures, understand the risks, and/or unwilling to provide written informed consent.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cah - congenital adrenal hyperplasia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency congenital adrenal hyperplasia

As listed by the trial registrant

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

Cah - congenital adrenal hyperplasia Congenital adrenal hyperplasia

Contacts and locations

Locations

  • Spruce Biosciences Clinical Site

    Orange, California, 92123, United States

  • Spruce Biosciences Clinical Site

    San Diego, California, 92123, United States

  • Spruce Biosciences Clinical Site

    Melbourne, Florida, 32935, United States

  • Spruce Biosciences Clinical Site

    Atlanta, Georgia, 30046, United States

  • Spruce Biosciences Clinical Site

    Indianapolis, Indiana, 46202, United States

  • Spruce Biosciences Clinical Site

    Ann Arbor, Michigan, 48109, United States

  • Spruce Biosciences Clinical Site

    Minneapolis, Minnesota, 55414, United States

  • Spruce Biosciences Clinical Site

    Las Vegas, Nevada, 89148, United States

  • Spruce Biosciences Clinical Site

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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