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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Oral tablet formulation taken once daily.
Non-active dosage form taken once daily.
Spruce Study Site
Sacramento, California, United States
Spruce Study Site
San Francisco, California, United States
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)
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Spruce Study Site
New Haven, Connecticut, United States
Spruce Study Site
Clearwater, Florida, United States
Spruce Study Site
Lake Worth, Florida, United States
Spruce Study Site
Miami, Florida, United States
Spruce Study Site
Winter Park, Florida, United States
Spruce Study Site
Idaho Falls, Idaho, United States
Spruce Study Site
Wichita, Kansas, United States
Spruce Study Site
Boston, Massachusetts, United States
...and 11 more locations