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Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial
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.
Age
18 - 40 years
Sex
FEMALE
Healthy Volunteers
No
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Women and Children's Hospital, School of Medicine, Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Start Date
April 16, 2025
Primary Completion Date
September 30, 2026
Completion Date
December 31, 2026
Last Updated
April 20, 2025
150
ESTIMATED participants
Dihydroartemisinin
DRUG
Placebo
DRUG
Lead Sponsor
Shanghai Zhongshan Hospital
NCT07129434
NCT06896981
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07396402