Efficacy of Dihydroartemisinin for Treating PCOS

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Dihydroartemisinin

• Registration Number: NCT06417099
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-12
• Study First Posted: 2024-05-16
• Study Start: 2024-05-24
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dihydroartemisinin Treatment Arm	Dihydroartemisinin	The subjects take dihydroartemisinin, 40mg tid for 90 days

Primary Outcome Measures

Name	Time	Method
Recovery of regular menses	180 days	Record of vaginal bleeding within 6 months after start taking dihydroartemisinin

Secondary Outcome Measures

Name	Time	Method
Free androgen index (FAI)	90 days	FAI (Total testosterone in nmol/L / SHBG in nmol/L X 100) before and after 90 days of medication
Number of immature follicles	90 days	Total number of immature follicles measuring 2-9 mm in diameter on ultrasound before and after 90 days of medication
Serum anti-Mullerian hormone (AMH)	90 days	Serum AMH before and after 90 days of medication

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China