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NCT05370521 · ClinicalTrials.gov registry record · Phase 2

A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens

A Phase 2 study, sponsored by Spruce Biosciences.

Terminated
Registry status
Phase 2
Development phase
27
Enrollment target

NCT05370521: Clinical Trial Phase 2 study, sponsored by Spruce Biosciences.

NCT05370521 is a Phase 2 study that was terminated before completion, run by Spruce Biosciences. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05370521, a Phase 2 study, was terminated before completion, sponsored by Spruce Biosciences.

TERMINATED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens

Primary Outcome

To evaluate the effect of tildacerfont in changing (reducing) DHEAS in subjects with PCOS and elevated adrenal androgens

Interventions

  • DRUG Placebo
  • DRUG Tildacerfont

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2022-05-15
Est. Completion 2023-08-31
Phase Phase 2
Spruce Biosciences

6 total trials

Why NCT05370521 stopped before completion

NCT05370521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05370521 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05370521 about?

NCT05370521 is a clinical study titled "A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens". An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens

What is the current status of trial NCT05370521?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2022-05-15. Estimated completion is 2023-08-31.

What interventions are being tested in trial NCT05370521?

The interventions under investigation include: Placebo (DRUG), Tildacerfont (DRUG).

Who is sponsoring clinical trial NCT05370521?

This trial is sponsored by Spruce Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05370521's enrollment target sits among peer trials

27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05370521, the US trial registry maintained by the National Library of Medicine. NCT05370521 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.