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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tildacerfont
Placebo
Sponsored by
Spruce Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Elevated Adrenal Androgen, Adrenal Disorder, Polycystic Ovary Syndrome, Womens health

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female subjects aged 18 to 40 years old at Screening visit
  • Body Mass Index (BMI) =/< 38 kg/m2 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:

  • Hemoglobin A1C (HbA1C) >/= 6.5% at screening or diagnosis of diabetes

  • 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

Sites / Locations

  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site
  • Spruce Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment with Tildacerfont

Placebo Control Arm

Arm Description

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.

Subjects randomized in this arm will receive 12 weeks of oral matched-placebo tablet

Outcomes

Primary Outcome Measures

DHEAS level
Change from baseline in DHEAS level

Secondary Outcome Measures

Reduction in DHEAS
Proportion of subjects with >/=30% change from baseline in DHEAS
Normalization of DHEAS
Proportion of subjects with DHEAS =/< upper limit of normal for DHEAS
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

Full Information

First Posted
May 6, 2022
Last Updated
September 25, 2023
Sponsor
Spruce Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05370521
Brief Title
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
August 3, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spruce Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, Elevated Adrenal Androgen, Adrenal Disorder, Polycystic Ovary Syndrome, Womens health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind randomization performed by IRT
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Tildacerfont
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control Arm
Arm Type
Placebo Comparator
Arm Description
Subjects randomized in this arm will receive 12 weeks of oral matched-placebo tablet
Intervention Type
Drug
Intervention Name(s)
Tildacerfont
Other Intervention Name(s)
SPR001
Intervention Description
Oral tablet formulation taken once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Non-active dosage form taken once daily.
Primary Outcome Measure Information:
Title
DHEAS level
Description
Change from baseline in DHEAS level
Time Frame
12 Weeks (assessed at Baseline, Weeks 4, 8, and 12)
Secondary Outcome Measure Information:
Title
Reduction in DHEAS
Description
Proportion of subjects with >/=30% change from baseline in DHEAS
Time Frame
12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Title
Normalization of DHEAS
Description
Proportion of subjects with DHEAS =/< upper limit of normal for DHEAS
Time Frame
12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Title
Number of subjects with TEAE as assessed by CTCAE Version 5
Description
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility for females is based on gender assignment at birth.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: History of congenital adrenal hyperplasia (CAH), Cushing's syndrome, pituitary or adrenal disease Clinically significant hyperprolactinemia Thyroid stimulating hormone (TSH) <0.1 mU/mL or >4.5mU/mL at Screening Cortisol levels concerning for adrenal insufficiency 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Will Charlton, MD
Organizational Affiliation
Spruce Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Spruce Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Spruce Study Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Spruce Study Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Spruce Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Spruce Study Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Spruce Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Spruce Study Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Spruce Study Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Spruce Study Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Spruce Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Spruce Study Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Spruce Study Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Spruce Study Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Spruce Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Spruce Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Spruce Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Spruce Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Spruce Study Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Spruce Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Spruce Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Spruce Study Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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