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Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

NCT06842524 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

Dihydroartemisinin

Dihydroartemisinin tablets 40mg tid po for 90 days

DRUG

Placebo

Identical placebo tid for 90 days

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Xi Dong, MD · Reproductive Medicine Center, Zhongshan Hospital, Fudan University

  • Xiaoying Li, MD, PhD · Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

  • Jingjing Jiang, MD, PhD · Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

  • Ben Willem Mol, MD, PhD · Department of Obstetrics and Gynaecology, Monash University

  • Wentao Li, MD, PhD · National Perinatal Epidemiology and Statistics Unit, Centre for Big Data Research in Health, University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842524 on ClinicalTrials.gov