DHEAS versus Metformin in PCOS study
Research type
Research Study
Full title
Investigating the effect of oral DHEAS on adrenal and ovarian steroidogenesis in women with PCOS
IRAS ID
365917
Contact name
Thozhukat Sathyapalan
Contact email
Sponsor organisation
Hull University Teaching hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Polycystic ovary syndrome (PCOS) is a common condition affecting 6–20% of women of reproductive age. It causes high blood levels of male-type hormones, irregular periods, fertility problems, and metabolic issues such as insulin resistance, obesity, and higher risk of diabetes and heart disease. Symptoms like acne, unwanted hair growth, weight gain, and irregular periods can affect both physical and emotional wellbeing.
Around one-third of women with PCOS also have high levels of adrenal hormones (especially DHEAS), but the role of the adrenal glands in PCOS is still not well understood.
This study will compare two medicines—DHEA (a hormone supplement) and metformin (a medication that improves insulin sensitivity)—to see how they each affect steroid hormone production in the ovaries and adrenal glands. The medicines will be given at normal, licensed doses for 14 weeks, not to treat symptoms, but to help improve understanding on how they work.
The main outcome measure will be the change in levels of the hormone androstenedione. Other hormones, metabolic markers, and symptoms such as acne, hirsutism, and menstrual irregularity will also be assessed.
The study aims to:1. Find out how DHEA and Metformin affect androgens and other hormones levels.
2. Collect early data on symptoms and biochemical markers to guide future research.
Study Design
• Women aged 18–45 with PCOS, irregular periods, and high androgen levels can take part if they meet the criteria.
• Participants will be randomly assigned to take DHEA (25–50 mg/day) or metformin (500–1500 mg/day).
• Three study visits will take place over 14 weeks, plus two phone calls.
• Study activities will include; body measurements, liver scan (Fibroscan), blood tests and questionnaires.
• After the study, participants will return to their usual medical care.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
26/YH/0004
Date of REC Opinion
19 Feb 2026
REC opinion
Further Information Favourable Opinion