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New treatment option for Polycystic Ovary Syndrome (PCOS)
Official title Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT06842524
What this study is testing
What is Dihydroartemisinin?
Dihydroartemisinin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for polycystic ovary syndrome (pcos).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Women with PCOS defined as having irregular menstrual cycles and hyperandrogenism. Irregular menstrual cycles are defined as \ 35 days or \ 1.67...
- Body Mass Index (BMI) between 18.5 and 28 kg/M2
- Negative pregnancy test
- No plan for pregnancy in the coming 6 months
You likely can't join if
- Patients on oral contraceptives. A two-month washout period will be required prior to screening for patients on these agents. A one-month washout...
- Patients with liver disease defined as ALT or AST above normal range of each participating center, or total bilirubin\>30umol/L. Metabolic...
- 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...
- Patients diagnosed with Type 1 or Type 2 diabetes.
See the full eligibility criteria
- Women with PCOS defined as having irregular menstrual cycles and hyperandrogenism. Irregular menstrual cycles are defined as \ 35 days or \ 1.67 nmol/L measured by Elecsys Testosterone II (Roche Diagnostics). Hirsutism...
- Body Mass Index (BMI) between 18.5 and 28 kg/M2
- Negative pregnancy test
- No plan for pregnancy in the coming 6 months
- 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...
- 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...
- 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...
- 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...
- Patients who have undergone a bariatric surgery procedure within the past 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
- Shanghai, Shanghai Municipality, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China; Shanghai, Shanghai Municipality, China; Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.