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NCT Number: NCT05465135

The Effect of Dihydroartemisinin in PCOS

Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin also has some significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigators' previous studies discovered that Artemisinin dramatically reduced serum androgen levels and improved poly-cystic ovary syndrome(PCOS) in animals. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.

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Key information

Age range

16 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

About this study

Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by a combination of genetic and environmental factors. The pathogenesis of PCOS remains unclear. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin has significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigator's previous studies found that artemisinin and its derivatives could significantly promote uncoupling protein 1 (UCP1) transcription and the conversion of white fat to brown fat. Artemisinin derivatives upregulated the levels of genes critical for brown fat differentiation and function, accompanied by enhanced mitochondrial biosynthesis, demonstrating their potential to promote white fat browning and improve metabolism in rodent models. The investigators also observed that androgen levels in drug-induced PCOS rats were reduced, when treated with artemether analogs for prophylactic and therapeutic purposes, respectively. It is believed that the two core mechanisms in the pathogenesis of PCOS are excessive androgen synthesis and insulin resistance. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both serum androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms and control or even reverse the disease progression. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI 23-30kg/M2
  • No plan for pregnancy in the coming 6 months
  • Newly diagnosed PCOS, or PCOS without any medication for the past three months.
  • Patients should meet all the three following criteria:
  • Oligomenorrhea or amenorrhea: Oligomenorrhea is defined as more than 35 days between menstrual periods and less than 8 menstrual bleedings in the past year; amenorrhea is defined as more than 90 days between two menstrual bleedings.
  • Polycystic ovaries: ≥12 follicles in both ovaries (diameter<10mm), confirmed by ultrasound.
  • Elevated androgen levels: testosterone>1.67 nmol/L.

Exclusion criteria

  • Previously treated with steroids or other medications for PCOS in the past 3 months.
  • Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.
  • Pregnancy.
  • Patients with other serious diseases affecting heart, liver, kidney, or other major organs.
  • Patients with any type of cancer.

Treatment and study plan

Dihydroartemisinin

Drug

Dihydroartemisinin 40mg three times a day for 12 consecutive weeks.

Primary outcomes

  1. Recovery of regular menses by questionnaire

    Time frame: 12 weeks

    Periodical vaginal bleeding by questionnaire

  2. Bilateral ovary volume

    Time frame: 12 weeks

    Length, width and height of bilateral ovaries measured by B type ultrasound

  3. Number of immature follicles

    Time frame: 12 weeks

    Total number of follicles with diameters <10 mm measured by B type ultrasound

  4. Serum testosterone levels

    Time frame: 12 weeks

    Measurement of serum total testosterone

Secondary outcomes

  1. Serum anti-Mullerian hormone

    Time frame: 12 weeks

    Measurement of serum AMH

  2. Sex hormone binding globulin (SHBG)

    Time frame: 12 weeks

    Measurement of serum SHBG

  3. Serum dehydroepiandrosterone sulfate

    Time frame: 12 weeks after drug intervention

    Measurement of serum DHEA

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

The Evaluation of the Effect of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
May 17, 2024

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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