Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

NCT ID: NCT06842524

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2026-12-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dihydroartemisinin Arm

Dihydroartemisinin tablets 40mg tid for 90 days

Group Type: ACTIVE_COMPARATOR

Dihydroartemisinin

Intervention Type: DRUG

Dihydroartemisinin tablets 40mg tid po for 90 days

Placebo Arm

Idential placebo tid for 90 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical placebo tid for 90 days

Interventions

Dihydroartemisinin

Dihydroartemisinin tablets 40mg tid po for 90 days

Intervention Type: DRUG

Placebo

Identical placebo tid for 90 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with PCOS defined as having irregular menstrual cycles and hyperandrogenism. Irregular menstrual cycles are defined as < 21 or > 35 days or < 8 cycles per year. Hyperandrogenism refers to either hyperandrogenemia or hirsutism. Hyperandrogenemia will be defined as an elevated total testosterone >1.67 nmol/L measured by Elecsys Testosterone II (Roche Diagnostics). Hirsutism is determined by a modified Ferriman-Gallwey Score >4 at screening exam.
• Body Mass Index (BMI) between 18.5 and 28 kg/M2
• Negative pregnancy test
• No plan for pregnancy in the coming 6 months

Exclusion Criteria

• Patients on oral contraceptives. A two-month washout period will be required prior to screening for patients on these agents. A one-month washout will be required for patients on oral cyclic progestins. Patients on depo-progestins or hormonal implants are excluded.
• Patients with liver disease defined as ALT or AST above normal range of each participating center, or total bilirubin>30umol/L. Metabolic dysfunction-associated steatotic liver disease (MASLD) with normal ALT and AST can be included.
• Patients with anemia (Hemoglobin < 12 g/dL) or neutropenia (neutrocyte <1.8×10^9/L).
• Patients with renal disease defined as serum creatinine> 115umol/L.
• Patients diagnosed with other endocrine diseases that are known to cause secondary polycystic ovary morphology, e.g., Cushing's syndrome, hyperprolactinemia, congenital adrenal hyperplasia (21-hydroxylase deficiency or other enzyme deficiency), hypothyroidism, etc.
• Patients diagnosed with Type 1 or Type 2 diabetes.
• Patients with known heart disease, like heart failure, atrial fibrillation, coronary heart disease, etc.
• Patients with a history of any type of cancer.
• Patients taking other medications known to affect reproductive function or metabolism. These medications include GnRH agonists and antagonists, antiandrogens, gonadotropins, GLP-1 receptor agonist, SGLT2i, metformin and thiazolidinediones. The washout period on all these medications will be two months.
• Patients who have undergone a bariatric surgery procedure within the past 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xi Dong, MD

Role: STUDY_CHAIR

Reproductive Medicine Center, Zhongshan Hospital, Fudan University

Xiaoying Li, MD, PhD

Role: STUDY_DIRECTOR

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

Jingjing Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University

Ben Willem Mol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynaecology, Monash University

Wentao Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Perinatal Epidemiology and Statistics Unit, Centre for Big Data Research in Health, University of New South Wales

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Women and Children's Hospital, School of Medicine, Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liangshan Mu, MD, PhD

Role: CONTACT

mu.liangshan@zs-hospital.sh.cn

86-021-64041990

Facility Contacts

Xin Zheng, MD

Role: primary

zx2001528@163.com

86-0592-2132222

Rongjuan Chen, MD

Role: primary

crj19910422@163.com

86-0592-2662020

Liangshan Mu, MD, PhD

Role: primary

mu.liangshan@zs-hospital.sh.cn

86-021-64041990

Xiaojing Lin, MD

Role: primary

llxxjj12@163.com

86-0577-55579999

Other Identifiers

B2024-417(2)

Identifier Type: -

Identifier Source: org_study_id