Efficacy of Dihydroartemisinin for Treating PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417099
• Other study ID #: B2020-115(2)
• Status: Recruiting
• Phase: Phase 2
• Start date: May 24, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Shanghai Zhongshan Hospital
• Contact: JINGJING JIANG, MD, PhD
• Phone: +862164041990
• Email: jiang.jingjing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of PCOS subjects who meet at least two of three Rotterdam Criteria. Secondary research hypotheses include: dihydroartemisinin is also effective in reducing androgen, total immature follicles, and anti-Mullerian hormone.

Description:

Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by genetic and environmental factors. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, artemisinin has also been reported to have significant anti-inflammatory, anti-tumor and immune-modulating effects. Our recent study revealed that artemisinin derivatives protect against PCOS development by inhibiting ovarian androgen production. Consistently in a small pilot study, dihydroartemisinin effectively reduced androgen levels, reduced immature follicles, and improved the estrous cycle in PCOS patients who strictly met all the three Rotterdam Criteria, namely hyperandrogenism, ovulation dysfunction, and polycystic ovaries on ultrasound. Nevertheless, clinical diagnosis of PCOS can be established as long as a patient fulfill two of the three Rotterdam Criteria. The present study aims to explore the therapeutic effects of dihydroartemisinin in patients with PCOS who met at least two of three (≥2) Rotterdam Criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI 18.5-28kg/M2

• No plan for pregnancy in the coming 6 months

• Patients should meet two of the three following criteria:

1. Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle

2. Polycystic ovaries: =12 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound.

3. Elevated androgen levels: total testosterone>1.67 nmol/L.

Exclusion Criteria:

• Pregnancy.

• Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.

• 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 tid po for 90 consecutive days

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	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	Record of vaginal bleeding within 6 months after start taking dihydroartemisinin	180 days
Secondary	Serum anti-Mullerian hormone (AMH)	Serum AMH before and after 90 days of medication	90 days
Secondary	Free androgen index (FAI)	FAI (Total testosterone in nmol/L / SHBG in nmol/L X 100) before and after 90 days of medication	90 days
Secondary	Number of immature follicles	Total number of immature follicles measuring 2-9 mm in diameter on ultrasound before and after 90 days of medication	90 days