Using Dihydroartemisinin to treat Polycystic Ovary Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mu.liangshan@zs-hospital.sh.cn
• Phone: 86-021-64041990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using LC-MS/MS to profile androgens for PCOS diagnosis

  This study tests whether LC-MS/MS measurement of androgen profiles can help diagnose PCOS in women compared with healthy controls.

  Recruiting Women's Hospital School Of Medicine Zhejiang University · Hangzhou, Zhejiang · NCT07916909

• Brown adipose tissue responses in PCOS with infrared thermography and inositol

  This study tests whether brown fat activity, measured by infrared skin temperature and UCP-1 levels, differs among women with PCOS (normal weight or overweight/obese) and healthy controls, and whether 12 weeks of inositol changes those responses in overweight/obese PCOS participants.

  Recruiting at 2 sites Istanbul Health and Technology University · Istanbul and 1 other locations · NCT07896642

• Risk tool for blood-clotting problems in adolescents and women with PCOS

  This project will try to build a risk model to spot decreased protein C or S and other clotting abnormalities in females aged 14–45 who have PCOS.

  Recruiting Guangdong Women and Children Hospital · Guangzhou, Guangdong · NCT07571096

• Polycystic Ovary Syndrome in Type 1 Diabetes

  This study tests whether women with type 1 diabetes and PCOS differ from other groups in factors that drive androgen excess and what that means for health.

  Recruiting Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Madrid, Madrid · NCT07490964

• PPOS versus GnRH antagonist IVF protocols for women with PCOS

  This trial will test whether a progestin-primed ovarian stimulation (PPOS) protocol or a GnRH antagonist protocol gives better IVF outcomes for women aged 18–40 with PCOS.

  Recruiting Hanoi General Hospital (Vietnam) · Hanoi, Hanoi · NCT07394530

• Detailed health profiling for people with PCOS

  This effort will collect clinical, hormonal (including AMH), and imaging information from adult women seen at Strasbourg University Hospital with suspected or confirmed PCOS to try to better define PCOS types.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07339930

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.