OncoMatch/Clinical Trials/NCT06842524
Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
Is NCT06842524 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Dihydroartemisinin for polycystic ovary syndrome (pcos).
Treatment: Dihydroartemisinin — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: oral contraceptive
Exception: two-month washout period prior to screening
Patients on oral contraceptives. A two-month washout period will be required prior to screening for patients on these agents.
Cannot have received: oral cyclic progestin
Exception: one-month washout period prior to screening
A one-month washout will be required for patients on oral cyclic progestins.
Cannot have received: depo-progestin
Patients on depo-progestins or hormonal implants are excluded.
Cannot have received: hormonal implant
Patients on depo-progestins or hormonal implants are excluded.
Cannot have received: GnRH agonist
Exception: two-month washout period prior to screening
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.
Cannot have received: GnRH antagonist
Exception: two-month washout period prior to screening
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.
Cannot have received: antiandrogen
Exception: two-month washout period prior to screening
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.
Cannot have received: gonadotropin
Exception: two-month washout period prior to screening
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.
Cannot have received: GLP-1 receptor agonist
Exception: two-month washout period prior to screening
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.
Cannot have received: SGLT2 inhibitor
Exception: two-month washout period prior to screening
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.
Cannot have received: metformin
Exception: two-month washout period prior to screening
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.
Cannot have received: thiazolidinedione
Exception: two-month washout period prior to screening
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.
Lab requirements
Blood counts
anemia (Hemoglobin <12 g/dL) or neutropenia (neutrocyte <1.8×10^9/L) excluded
Kidney function
serum creatinine >115 umol/L excluded
Liver function
ALT or AST above normal range of each participating center, or total bilirubin >30 umol/L excluded; MASLD with normal ALT and AST can be included
Patients with liver disease defined as ALT or AST above normal range... or total bilirubin>30umol/L. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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