The Effect of Dihydroartemisinin in PCOS

• Status: Active, not recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Artenimol

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.