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Corticosteroid

Tildacerfont for Polycystic Ovary Syndrome

Phase 2
Waitlist Available
Research Sponsored by Spruce Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (assessed at baseline, weeks 4, 8 and 12)
Awards & highlights

Study Summary

This trial looks at whether tildacerfont is safe and effective in women with PCOS who also have high levels of adrenal androgens.

Eligible Conditions
  • Polycystic Ovary Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (assessed at baseline, weeks 4, 8 and 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (assessed at baseline, weeks 4, 8 and 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DHEAS level
Secondary outcome measures
Normalization of DHEAS
Number of subjects with TEAE as assessed by CTCAE Version 5
Reduction in DHEAS

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment with TildacerfontExperimental Treatment1 Intervention
Subjects randomized in this arm will receive 4 weeks of 50mg of oral tildacerfont tablet, followed by 4 weeks of 100 mg oral tildacerfont tablet, and then 4 weeks of 200 mg oral tildacerfont tablet for a total of 12 weeks of treatment.
Group II: Placebo Control ArmPlacebo Group1 Intervention
Subjects randomized in this arm will receive 12 weeks of oral matched-placebo tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tildacerfont
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Spruce BiosciencesLead Sponsor
5 Previous Clinical Trials
278 Total Patients Enrolled
Will Charlton, MDStudy DirectorSpruce Biosciences
6 Previous Clinical Trials
676 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a volunteer for this medical research?

"Candidates of this trial should possess sclerocystic ovaries and be situated between 18 and 40 years old. Currently, the research team is recruiting 39 participants."

Answered by AI

What is the participant capacity for this research study?

"Affirmative. According to the publicly available data on clinicaltrials.gov, this medical experiment has been live since May 15th 2022 and is currently looking for 39 participants across 8 different trial sites."

Answered by AI

Does this research encompass older individuals of 65 or more years?

"According to the trial's inclusion criteria, any potential participants must fall between 18 and 40 years old."

Answered by AI

Are individuals currently being welcomed to join this research?

"Affirmative. According to the clinicaltrials.gov website, this trial is presently recruiting participants with an initial posting date of May 15th 2022 and a last updated date of November 15th 2022. The study requires 39 patients from 8 sites in total."

Answered by AI

Are there numerous North American locations involved in this trial?

"At present, 8 sites are enrolling participants for this medical trial. These include Philadelphia, Clearwater and Fall River as well as other cities across the country. To reduce travel burdens, it is beneficial to select a site closest to you when signing up for the study."

Answered by AI

Has Tildacerfont been verified by the FDA?

"It has been deemed that tildacerfont possesses a safety ranking of 2, as there is evidence pointing to its harmlessness but no empirical data indicating any effectiveness."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
Other
Florida
How old are they?
18 - 65
What site did they apply to?
Spruce Study Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2

Why did patients apply to this trial?

I was just curious how this study works. I am having trouble with getting pregnant due to my PCOS. I want to try something new.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does the whole process take? How soon can I start?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
2022. "A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370521.
~9 spots leftby Apr 2025
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