Tests dihydroartemisinin for polycystic ovary syndrome in women
Tests whether dihydroartemisinin or placebo helps women with polycystic ovary syndrome.
Plain-language title generated from the registry record
Registry title: Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
Key facts
- Where
- Shanghai, Wenzhou, and Xiamen, ChinaSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 40 with polycystic ovary syndrome (PCOS), with irregular periods and high male hormone levels or excess hair growth. It tests dihydroartemisinin against a placebo.
- Age
- 18 to 40 years
- Sex
- Women only
- Disease stage
- PCOS with irregular menstrual cycles (less than 21 or more than 35 days, or fewer than 8 cycles per year) and hyperandrogenism: total testosterone above 1.67 nmol/L, or hirsutism with a modified Ferriman-Gallwey Score above 4.
- Earlier treatment
- No oral contraceptives (2-month washout), no oral cyclic progestins (1-month washout). No GnRH agonists or antagonists, antiandrogens, gonadotropins, GLP-1 receptor agonists, SGLT2i, metformin or thiazolidinediones (2-month washout). No bariatric surgery in the past 12 months.
- Biomarker or test result
- Total testosterone above 1.67 nmol/L (Elecsys Testosterone II) or a modified Ferriman-Gallwey Score above 4. Body Mass Index (BMI) between 18.5 and 28 kg/M2. Negative pregnancy test.
Main reasons for not taking part
- Planning a pregnancy in the next 6 months
- Liver disease, kidney disease, anemia or neutropenia
- Type 1 or Type 2 diabetes
- Known heart disease or any history of cancer
- Other endocrine diseases that cause polycystic ovaries, such as Cushing's syndrome or hypothyroidism
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT06842524, who can take part
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Liangshan Mu, MD, PhDTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Xiaojing Lin, MDTaking people
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Xin Zheng, MDTaking people
- Women and Children's Hospital, School of Medicine, Xiamen UniversityXiamen, ChinaContact: Rongjuan Chen, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT06842524
- Record updated
- 20 April 2025
- Original description
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.Read full original descriptionShow less
Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial
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.
Inclusion: 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: 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 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; 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 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.