RecruitingPhase 2NCT06842524

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial


Sponsor

Shanghai Zhongshan Hospital

Enrollment

150 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called dihydroartemisinin — originally used to treat malaria — can help women with polycystic ovary syndrome (PCOS), a hormonal condition that causes irregular periods and excess androgen hormones. **You may be eligible if...** - You are a woman with PCOS (irregular periods and high testosterone or excess body hair) - Your BMI is between 18.5 and 28 - You are not pregnant and do not plan to become pregnant in the next 6 months **You may NOT be eligible if...** - You are currently on hormonal birth control (a washout period may apply) - You have liver disease, anemia, low white blood cell count, or kidney problems - You have diabetes (Type 1 or Type 2) - You have a known heart condition - You have a history of cancer - You take other medications that affect hormones or metabolism (e.g., metformin, GLP-1 drugs) - You had bariatric surgery in the last 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDihydroartemisinin

Dihydroartemisinin tablets 40mg tid po for 90 days

DRUGPlacebo

Identical placebo tid for 90 days


Locations(4)

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

View Full Details on ClinicalTrials.gov

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NCT06842524


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