The Effect of Dihydroartemisinin in PCOS

NCT ID: NCT05465135

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-04-23

Brief 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.

Detailed 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dihydroartemisinin Group

The subjects take Dihydroartemisinin, 40mg tid for 12 weeks

Group Type: EXPERIMENTAL

Dihydroartemisinin

Intervention Type: DRUG

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

Interventions

Dihydroartemisinin

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

Intervention Type: DRUG

Eligibility Criteria

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:

1. 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.

2. Polycystic ovaries: ≥12 follicles in both ovaries (diameter<10mm), confirmed by ultrasound.

3. 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaoying Li

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoying Li, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital Fudan University

Shanghai, , China

Countries

China

Other Identifiers

B2020-115R

Identifier Type: -

Identifier Source: org_study_id