Using Dihydroartemisinin to treat Polycystic Ovary Syndrome

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

This study is testing if a medication called dihydroartemisinin can help women with Polycystic Ovary Syndrome (PCOS) feel better by improving their menstrual cycles and hormone levels.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 4 sites (Xiamen, Fujian and 3 other locations)
• Trial ID: NCT06842524 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of dihydroartemisinin in women diagnosed with Polycystic Ovary Syndrome (PCOS), characterized by irregular menstrual cycles and hyperandrogenism. The study aims to determine whether dihydroartemisinin can improve symptoms associated with PCOS, such as menstrual irregularity and elevated androgen levels. Participants will be randomly assigned to receive either dihydroartemisinin or a placebo, with the goal of assessing the treatment's effectiveness compared to no active intervention. The trial builds on previous findings that suggest dihydroartemisinin may enhance insulin sensitivity and reduce hyperandrogenemia in PCOS patients.

Who should consider this trial

Good fit: Ideal candidates for this study are women with PCOS who have irregular menstrual cycles and hyperandrogenism, and who are not planning to become pregnant in the next six months.

Not a fit: Patients currently using oral contraceptives or those with liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for women with PCOS, potentially improving their symptoms and quality of life.

How similar studies have performed: Previous studies have shown promising results with dihydroartemisinin in small cohorts, suggesting potential efficacy, but this approach is still being evaluated in a larger context.

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.

Where this trial is running

Xiamen, Fujian and 3 other locations

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• Women and Children's Hospital, School of Medicine, Xiamen University — Xiamen, Fujian, China (Recruiting)
• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jingjing Jiang, MD, PhD — Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
• Study coordinator: Liangshan Mu, MD, PhD

Conditions Polycystic Ovary Syndrome; Dihydroartemisinin