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A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
Phase 2 trial testing Tildacerfont in Polycystic Ovary Syndrome in 27 participants. Terminated before completion.
| Lead sponsor | Spruce Biosciences |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 15 May 2022 |
| Primary completion | 3 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 21 locations across United States |
Spruce Biosciences — full company profile →
Adults 18 to 40, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of subjects with \>/=30% change from baseline in DHEAS
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Tildacerfont | 1 | |
| Placebo Control Arm | 1 |
Number of subjects with DHEAS =/\< upper limit of normal for DHEAS
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Tildacerfont | 8 | |
| Placebo Control Arm | 6 |
Evaluation of safety of tildacerfont with PCOS as measured by number of subjects with adverse events following dosing by CTCAE Version 5
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Tildacerfont | 13 | |
| Placebo Control Arm | 9 |
To evaluate the effect of tildacerfont in changing (reducing) DHEAS in subjects with PCOS and elevated adrenal androgens
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Tildacerfont | -22.93 | ± 67.600 |
| Placebo Control Arm | -7.56 | ± 16.00 |
Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|---|
| Obstructive pancreatitis | Gastrointestinal disorders | — | — |
| Reaction | System | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Abdominal pain lower | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — |
| Vertigo positional | Ear and labyrinth disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| COVID-19 | Infections and infestations | — | — |
| Vulvovaginal mycotic infection | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Oral herpes | Infections and infestations | — | — |
| Otitis media | Infections and infestations | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Viral rhinitis | Infections and infestations | — | — |
| Blood potassium increased | Investigations | — | — |
| Total bile acids increased | Investigations | — | — |
| Weight increased | Investigations | — | — |
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Headache | Nervous system disorders | — | — |
| Tension headache | Nervous system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Mood swings | Psychiatric disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruitis | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Gastrointestinal Pain | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Obstructive pancreatitis.
Data from ClinicalTrials.gov NCT05370521 adverse events section.
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
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