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NCT Number: NCT06842524

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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 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.
  • 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 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.

Treatment and study plan

Dihydroartemisinin

Drug

Dihydroartemisinin tablets 40mg tid po for 90 days

Placebo

Drug

Identical placebo tid for 90 days

Primary outcomes

  1. The occurrence of a regular menstrual cycle

    Time frame: From the start of treatment to the end of follow-up at 26 weeks

    The occurrence of a regular menstrual cycle is defined as at least three consecutive spontaneous vaginal bleedings lasting for 2-7 days, with intervals between the start of each cycle of 21 and 35 days (inclusive), during the 26-week period after initiating treatment.

Secondary outcomes

  1. The presence of a dominant follicle

    Time frame: From the start of treatment to the end of follow-up at 26 weeks

    This will be verified by transvaginal/transanal ultrasound before predicted ovulation, or testing serum progesterone in the predicted mid-luteal phase (A progesterone level>16nmol/L or 5ng/ml is suggestive of ovulation) in those with at least two consecutive spontaneous bleedings.

  2. The number of bilateral antral follicles

    Time frame: Before and immediately after 90-day treatment

    This will be measured by transvaginal/transanal ultrasound before and immediately after 90-day treatment. Antral follicles are defined as follicles measuring 2-9 mm in diameter in the ovary.

  3. Serum AMH

    Time frame: Before and immediately after 90-day treatment

    This will be measured before and immediately after 90-day treatment.

  4. Serum total testosterone

    Time frame: Before and immediately after 90-day treatment

    This will be measured before and immediately after 90-day treatment.

  5. Serum sex hormone binding globulin (SHBG)

    Time frame: Before and immediately after 90-day treatment

    This will be measured before and immediately after 90-day treatment.

  6. free androgen index (FAI)

    Time frame: Before and immediately after 90-day treatment

    This will be calculated before and immediately after 90-day treatment. FAI is calculated from measurable values for total testosterone and SHBG, using the following equation: FAI = (Total testosterone in nmol/L / SHBG in nmol/L) × 100.

  7. HOMA-IR

    Time frame: Before and immediately after 90-day treatment

    HOMA-IR will be calculated before and immediately after 90-day treatment. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5.

Study contacts

Contact information is provided by the study sponsor or research team.

Liangshan Mu, MD, PhD

CONTACT

[email protected]

86-021-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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