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Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial
Led by Shanghai Zhongshan Hospital · Updated on 2025-04-20
150
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Polycystic ovary syndrome (PCOS) is a common hormone disorder affecting women of reproductive age, characterized by irregular menstrual cycles, excess male hormones, and ovaries with multiple cysts. Researchers are studying the effects of dihydroartemisinin, a drug that has shown promise in improving hormone levels and menstrual regularity in earlier studies, to see if it can help women with PCOS in a controlled clinical trial. The trial aims to evaluate whether this treatment can restore regular menstrual cycles over six months, along with improvements in ovarian follicles and metabolism. Participants will receive either dihydroartemisinin tablets at a dose of 40 mg three times daily or a matching placebo for 90 days. This is a randomized, placebo-controlled study with two groups, and both participants and study staff will not know who receives the active drug or placebo during the trial. Treatment effects will be monitored over a 26-week follow-up period after the start of treatment to assess menstrual cycle regularity and other hormonal and metabolic outcomes. Women in the study will undergo evaluations including hormone blood tests, ultrasound scans to count ovarian follicles, and assessments of metabolic markers before and immediately after treatment. Researchers will track the return of regular menstrual cycles during the six months following treatment start. Safety and adherence will be monitored throughout the trial period. Total participation will last about six months, including treatment and follow-up visits.
CONDITIONS
Brief Title
Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with PCOS characterized by irregular menstrual cycles (<21 or >35 days or <8 cycles per year) and hyperandrogenism (either high total testosterone >1.67 nmol/L or hirsutism with Ferriman-Gallwey score >4)
- Body Mass Index (BMI) between 18.5 and 28 kg/m2
- Negative pregnancy test at screening
- No plan for pregnancy during the next 6 months
You will not qualify if you...
- Use of oral contraceptives (2-month washout required) or oral cyclic progestins (1-month washout required); use of depo-progestins or hormonal implants excluded
- Liver disease with elevated ALT or AST or total bilirubin >30 umol/L; MASLD with normal liver enzymes allowed
- Anemia with hemoglobin <12 g/dL or neutropenia with neutrocyte count <1.8x10^9/L
- Renal disease with serum creatinine >115 umol/L
- Other endocrine diseases causing secondary polycystic ovary morphology such as Cushing's syndrome, hyperprolactinemia, congenital adrenal hyperplasia, hypothyroidism
- Diagnosis of Type 1 or Type 2 diabetes
- Known heart disease including heart failure, atrial fibrillation, coronary heart disease
- History of any cancer
- Use of medications affecting reproduction or metabolism (GnRH agonists/antagonists, antiandrogens, gonadotropins, GLP-1 receptor agonists, SGLT2 inhibitors, metformin, thiazolidinediones) with 2-month washout
- Bariatric surgery within past 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 90 days
Participants take Dihydroartemisinin tablets or placebo three times daily for 90 days.
Visits before and immediately after treatment
Duration - Up to 26 weeks after treatment
Participants are monitored to assess the occurrence of a regular menstrual cycle and other outcomes after treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 4 locations
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
2
Women and Children's Hospital, School of Medicine, Xiamen University
Xiamen, Fujian, China, 361003
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3
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
4
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
L
Liangshan Mu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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