The Effect of Dihydroartemisinin in PCOS

Phase

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Dihydroartemisinin

Clinical Study ID

NCT05465135

B2020-115R

Ages 16-35
Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 daysbetween 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 byultrasound.
Elevated androgen levels: testosterone>1.67 nmol/L.

Exclusion

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 butnot limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing'ssyndrome, etc.
Pregnancy.
Patients with other serious diseases affecting heart, liver, kidney, or other majororgans.
Patients with any type of cancer.

Study Design

Dihydroartemisinin

July 01, 2022

April 23, 2023

Study Description

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.

Connect with a study center

Zhongshan Hospital Fudan University
Shanghai, 200032
China
Site Not Available

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