Actively Recruiting
Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
Led by Shanghai Zhongshan Hospital · Updated on 2025-04-20
150
Participants Needed
4
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with PCOS having irregular menstrual cycles (less than 21 days, more than 35 days, or fewer than 8 cycles per year) and hyperandrogenism (high testosterone or excessive hair growth)
- Body Mass Index between 18.5 and 28 kg/m2
- Negative pregnancy test at screening
- No plans for pregnancy in the next 6 months
You will not qualify if you...
- Current use of oral contraceptives without a 2-month washout, oral cyclic progestins without a 1-month washout, or use of depo-progestins or hormonal implants
- Liver disease with elevated liver enzymes or high bilirubin, except metabolic dysfunction-associated steatotic liver disease with normal enzymes
- Anemia (hemoglobin less than 12 g/dL) or neutropenia (neutrocyte count less than 1.8 x 10^9/L)
- Kidney disease with serum creatinine above 115 umol/L
- Other endocrine disorders causing secondary PCOS, such as Cushing's syndrome, hyperprolactinemia, congenital adrenal hyperplasia, or hypothyroidism
- Diagnosis of Type 1 or Type 2 diabetes
- Known heart diseases like heart failure, atrial fibrillation, or coronary heart disease
- History of any cancer
- Use of medications affecting reproduction or metabolism, including GnRH agonists/antagonists, antiandrogens, gonadotropins, GLP-1 receptor agonists, SGLT2 inhibitors, metformin, or thiazolidinediones without a 2-month washout
- Bariatric surgery within the past 12 months
AI-Screening
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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
Actively Recruiting
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
CONTACT
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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