Cure My Disease

Don't miss your cure!

 Log in / Sign up

PCOS drug trial halted early: did tildacerfont lower hormones?

NCT ID NCT05370521

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a drug called tildacerfont in 27 women with polycystic ovary syndrome (PCOS) who had high levels of adrenal androgens (hormones). The goal was to see if the drug could safely lower these hormones. The trial was stopped early, so results are limited.

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

27 people

The number who actually took part.

Started

May 2022

Finished

Aug 2023

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 to 40 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: * Female subjects aged 18 to 40 years old at Screening visit * Diagnosis of PCOS (either historical or during Screening) according to NIH (1990) criteria * DHEAS level \> age-matched upper limit of normal (ULN) at Screening visit * Agree to follow industry standard contraception guidelines within protocol Exclusion Criteria: * Evidence of: 1. History of congenital adrenal hyperplasia (CAH), Cushing's syndrome, pituitary or adrenal disease 2. Clinically significant hyperprolactinemia 3. Thyroid stimulating hormone (TSH) \<0.1 mU/mL or \>4.5mU/mL at Screening 4. Cortisol levels concerning for adrenal insufficiency 5. Other findings suggestive of secondary cause for anovulation and/or hyperandrogenemia * Total testosterone levels \>140 ng/dL, DHEAS \>650 mcg/dL, virilization or other signs or symptoms concerning for ovarian hyperthecosis or androgen-secreting tumors * Medical conditions that require glucocorticoid treatment within 30 days of screening and throughout the duration of the study * Clinically significant unstable medical conditions, illness, or chronic diseases * Prior hysterectomy or bilateral oophorectomy * Females who are pregnant or nursing

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Polycystic ovary syndrome are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

adrenal gland disorder polycystic ovary syndrome

As listed by the trial registrant

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

Polycystic ovary syndrome

Contacts and locations

Locations

  • Spruce Study Site

    Sacramento, California, 95817, United States

  • Spruce Study Site

    San Francisco, California, 94158, United States

  • Spruce Study Site

    New Haven, Connecticut, 06519, United States

  • Spruce Study Site

    Clearwater, Florida, 33759, United States

  • Spruce Study Site

    Lake Worth, Florida, 33461, United States

  • Spruce Study Site

    Miami, Florida, 33173, United States

  • Spruce Study Site

    Winter Park, Florida, 32792, United States

  • Spruce Study Site

    Idaho Falls, Idaho, 83404, United States

  • Spruce Study Site

    Wichita, Kansas, 67226, United States

  • Spruce Study Site

    Boston, Massachusetts, 02115, United States

  • Spruce Study Site

    Fall River, Massachusetts, 02720, United States

  • Spruce Study Site

    Southfield, Michigan, 48034, United States

  • Spruce Study Site

    Williamsville, New York, 14221, United States

  • Spruce Study Site

    Raleigh, North Carolina, 27612, United States

  • Spruce Study Site

    Cincinnati, Ohio, 45219, United States

  • Spruce Study Site

    Cleveland, Ohio, 44106, United States

  • Spruce Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Spruce Study Site

    Bedford, Texas, 76022, United States

  • Spruce Study Site

    Houston, Texas, 77024, United States

  • Spruce Study Site

    Houston, Texas, 77030, United States

  • Spruce Study Site

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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