The P.O.W.E.R. study is seeking women with Polycystic Ovary Syndrome (PCOS) in the United States.
Through the P.O.W.E.R. study, Spruce Biosciences is evaluating tildacerfont, an investigational drug that may reduce the amount of androgens (male hormones) in women with PCOS.
The purpose of The P.O.W.E.R. study:
Who can take part in the P.O.W.E.R. study?(1)
- Females between 18 to 40 years old
- Diagnosed with Polycystic Ovary Syndrome (PCOS)
- Not pregnant, breastfeeding, or trying to become pregnant in the next 6 months
- Not diagnosed with congenital adrenal hyperplasia (CAH) or Cushing’s syndrome
What is the time commitment for the P.O.W.E.R. study?
- The study will take about five months to complete with five to six clinic visits and three phone calls
What is tildacerfont?
Tildacerfont belongs to a group of drugs known as CRF1 receptor antagonists. By blocking CRF1 receptors on the pituitary gland, tildacerfont has been shown to decrease the signal that causes excessive production of adrenal androgen hormones. This may help improve the symptoms experienced by women with PCOS like excess hair growth, acne, irregular periods, and infertility.
Is tildacerfont safe?
Tildacerfont is generally well-tolerated in healthy volunteers and in people with rare endocrine conditions.
- Generally well-tolerated across a diverse group of people
- Generally well-tolerated at doses under evaluation
- No reported drug-related serious adverse events (SAEs)
Finding the support you need
The Spruce Patient Engagement Team
Living with a rare endocrine condition can be a complex journey at times that you don’t have to navigate alone. The Spruce Patient Engagement Team offers personalized support and access to resources for people living with androgen- mediated polycystic ovary syndrome (PCOS).
Spruce Patient Engagement Liaisons (PELs) work closely with individuals, families, advocacy groups, and healthcare providers to better understand the needs of these communities. PELs provide education and resources related to these conditions and serve as contact for local advocacy and support groups.
Connecting with organizations and local support groups can help people understand more about their condition and meet others in the PCOS community.
These groups and websites are neither owned nor controlled by Spruce Biosciences. Spruce does not endorse and is not responsible for the content or services they provide..
The purpose of the Spruce Patient Education Liaison (PEL) is to provide education to patients, their families, and caregivers. PELs are employees of Spruce Biosciences. They are not acting as healthcare providers and are not part of your healthcare team. PELs do not provide medical care or advice. All diagnosis and treatment decisions should be made by you and your healthcare team.
“I am proud to serve as a trusted resource and
advocate for members of the PCOS community.”
– Mara VanAndel
References: 1. Additional entry criteria applies; 2. Sarafoglou K, et al. J Clin Endocrinol Metab. 2021;106(11):e4666-e4679. doi:10.1210/clinem/dgab438;