Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

Summary

Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder affecting women of reproductive age, with a prevalence of 10 to 13%. PCOS is characterized by irregular menstrual cylcles/ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. For infertile patients seeking ovulation induction, letrozole is the drug of first choice. For PCOS patients not seeking pregnancy, there exists a variety of treatments to alleviate symptoms. It has been demonstrated that artemisinin derivatives can promote energy expenditures and insulin sensitivity by activating thermogenic adipocytes, thereby protecting against diet-induced obesity and metabolic disorders in rodents. Recently, we showed in a single arm pilot study including 19 PCOS-patients, that dihydroartemisinin ameliorated hyperandrogenemia reduced antral follicle count and normalized menstrual cycles. Based on these findings, we aim to evaluate the efficacy of dihydroartemisinin in women with PCOS in a placebo controlled randomized clinical trial. The primary outcome is return of regular menstrual cycles within 6 months after start of treatment, with antral follicle count and metabolic profile being secondary outcomes. The results will potentially impact the standard of care for patients diagnosed with PCOS.

Timeline

Start

2025-04-16

Primary completion

2026-09-30

Completion

2026-12-31

Publications

• Mu L, Shen Y, Wang G, Liu C, Yang H, Li W, Mol BW, Li X, Dong X, Jiang J. Dihydroartemisinin for the treatment of polycystic ovary syndrome: study protocol for a multi-centre placebo-controlled randomised clinical trial. BMJ Open. 2026 Jun 19;16(6):e108980. doi: 10.1136/bmjopen-2025-108980.

Drugs

Indications