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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370521
• Other study ID #: SPR001-210
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Spruce Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is 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 will be randomized 2:1 (tildacerfont:placebo) at baseline. The study will consist of 3 consecutive 4-week treatment periods at each dose level. Duration of participation is approximately 25 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 31, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Tildacerfont
Oral tablet formulation taken once daily.
• Placebo
Non-active dosage form taken once daily.

Locations

Country	Name	City	State
United States	Spruce Study Site	Bedford	Texas
United States	Spruce Study Site	Boston	Massachusetts
United States	Spruce Study Site	Cincinnati	Ohio
United States	Spruce Study Site	Clearwater	Florida
United States	Spruce Study Site	Cleveland	Ohio
United States	Spruce Study Site	Fall River	Massachusetts
United States	Spruce Study Site	Houston	Texas
United States	Spruce Study Site	Houston	Texas
United States	Spruce Study Site	Idaho Falls	Idaho
United States	Spruce Study Site	Lake Worth	Florida
United States	Spruce Study Site	Miami	Florida
United States	Spruce Study Site	Morgantown	West Virginia
United States	Spruce Study Site	New Haven	Connecticut
United States	Spruce Study Site	Philadelphia	Pennsylvania
United States	Spruce Study Site	Raleigh	North Carolina
United States	Spruce Study Site	Sacramento	California
United States	Spruce Study Site	San Francisco	California
United States	Spruce Study Site	Southfield	Michigan
United States	Spruce Study Site	Wichita	Kansas
United States	Spruce Study Site	Williamsville	New York
United States	Spruce Study Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Spruce Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DHEAS level	Change from baseline in DHEAS level	12 Weeks (assessed at Baseline, Weeks 4, 8, and 12)
Secondary	Reduction in DHEAS	Proportion of subjects with >/=30% change from baseline in DHEAS	12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Secondary	Normalization of DHEAS	Proportion of subjects with DHEAS =/< upper limit of normal for DHEAS	12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Secondary	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	12 weeks (assessed at Baseline, Weeks 4, 8 and 12)