The Effect of Dihydroartemisinin in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465135
• Other study ID #: B2020-115R
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: April 23, 2023

Study information

• Verified date: May 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of regular menses by questionnaire	Periodical vaginal bleeding by questionnaire	12 weeks
Primary	Bilateral ovary volume	Length, width and height of bilateral ovaries measured by B type ultrasound	12 weeks
Primary	Number of immature follicles	Total number of follicles with diameters <10 mm measured by B type ultrasound	12 weeks
Primary	Serum testosterone levels	Measurement of serum total testosterone	12 weeks
Secondary	Serum anti-Mullerian hormone	Measurement of serum AMH	12 weeks
Secondary	Sex hormone binding globulin (SHBG)	Measurement of serum SHBG	12 weeks
Secondary	Serum dehydroepiandrosterone sulfate	Measurement of serum DHEA	12 weeks after drug intervention