Clinical trial · Interventional
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
A Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of Tildacerfont in Adult Subjects With Polycystic Ovary Syndrome (PCOS) and Elevated Adrenal Androgens
NCT05370521CI-TRIAL-00096464terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued early by the sponsor
Summary
Brief summary (as posted)
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Tildacerfont | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment with Tildacerfont
- description
- Subjects randomized in this arm received 4 weeks of 50 mg 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.
- interventionNames
- Drug: Tildacerfont
- type
- PLACEBO_COMPARATOR
- label
- Placebo Control Arm
- description
- Subjects randomized in this arm received 12 weeks of oral matched-placebo tablet
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in DHEAS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.