A Phase 2 interventional study of Tildacerfont and Placebo in Polycystic Ovary Syndrome, sponsored by Spruce Biosciences. Terminated at 21 sites in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Spruce Biosciences · Phase 2, Interventional, and Treatment
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
This was a phase 2 study to evaluate the efficacy, safety and tolerability of 3 doses of tildacerfont in approximately 39 women with PCOS and elevated adrenal androgens assessed by elevated DHEAS levels. Subjects were randomized 2:1 (tildacerfont:placebo) at baseline. The study consisted of 3 consecutive 4-week treatment periods at each dose level. Duration of participation was approximately 25 weeks.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Spruce Biosciences is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Evidence of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tildacerfont
Subjects randomized in this arm received 12 weeks of oral matched-placebo tablet
Drug: Placebo
Oral tablet formulation taken once daily.
Also known as: SPR001
Non-active dosage form taken once daily.
Change in DHEAS
To evaluate the effect of tildacerfont in changing (reducing) DHEAS in subjects with PCOS and elevated adrenal androgens
Time frame: 12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Reduction in DHEAS
Number of subjects with \>/=30% change from baseline in DHEAS
Time frame: 12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Normalization of DHEAS
Number of subjects with DHEAS =/\< upper limit of normal for DHEAS
Time frame: 12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Number of Subjects With TEAE as Assessed by CTCAE Version 5
Evaluation of safety of tildacerfont with PCOS as measured by number of subjects with adverse events following dosing by CTCAE Version 5
Time frame: 12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Of the 82 subjects that were screened, a total of 27 subjects enrolled in the study (10 subjects in the placebo arm and 17 subjects in the tildacerfont arm).
| Milestone | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| Started | 17 | 10 |
| Completed | 16 | 9 |
| Not completed | 1 | 1 |
Number of subjects with \>/=30% change from baseline in DHEAS
| Participants | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| Reduction in DHEAS | 1 | 1 |
Number of subjects with DHEAS =/\< upper limit of normal for DHEAS
| Participants | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| Normalization of DHEAS | 8 | 6 |
Evaluation of safety of tildacerfont with PCOS as measured by number of subjects with adverse events following dosing by CTCAE Version 5
| Participants | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| Number of Subjects With TEAE as Assessed by CTCAE Version 5 | 13 | 9 |
To evaluate the effect of tildacerfont in changing (reducing) DHEAS in subjects with PCOS and elevated adrenal androgens
| ug/dL | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| Change in DHEAS | -22.93 ± 67.600 | -7.56 ± 16.00 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Tildacerfont | 0/17 (0%) | 1/17 (5.9%) | 13/17 (76.5%) |
| Placebo Control Arm | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Event | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| Obstructive pancreatitisGastrointestinal disorders | 1/17 | 0/10 |
| Event | Treatment With Tildacerfont | Placebo Control Arm |
|---|---|---|
| DiarrheaGastrointestinal disorders | 8/17 | 1/10 |
| FatigueGeneral disorders | 0/17 | 2/10 |
| AcneSkin and subcutaneous tissue disorders | 0/17 | 2/10 |
| Abdominal PainGastrointestinal disorders | 2/17 | 1/10 |
| Abdominal pain lowerGastrointestinal disorders | 2/17 | 0/10 |
| NasopharyngitisInfections and infestations | 2/17 | 1/10 |
| Vertigo positionalEar and labyrinth disorders | 0/17 | 1/10 |
| NauseaGastrointestinal disorders | 1/17 | 1/10 |
| COVID-19Infections and infestations | 1/17 | 1/10 |
| Vulvovaginal mycotic infectionInfections and infestations | 1/17 | 1/10 |
| Age, Categorical(Participants) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 10 | 27 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| Female | 17 | 10 | 27 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 15 | 9 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 6 | 13 |
| Not Hispanic or Latino | 10 | 4 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Dehydroepiandrosterone sulfate (DHEAS)(ug/dL) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| Mean | 351.3 ± 90.53 | 387.8 ± 107.16 | 364.8 ± 96.65 |
| Adrenocorticotropic hormone (ACTH)(pg/dL) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| Mean | 23.88 ± 11.927 | 22.3 ± 12.013 | 23.27 ± 11.744 |
| 17-hydroxyprogesterone (17-OHP)(ng/dL) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| Mean | 83.2 ± 86.28 | 62.1 ± 54.1 | 75.4 ± 75.51 |
| Androstenedione (A4)(ng/dL) | Treatment With Tildacerfont | Placebo Control Arm | Total |
|---|---|---|---|
| Mean | 185.2 ± 75.19 | 130.0 ± 65.96 | 166.8 ± 75.61 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tildacerfont
Spruce Biosciences