Efficacy of Dihydroartemisinin for Treating PCOS

Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Dihydroartemisinin

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JINGJING JIANG, MD, PhD; Phone Number: 692023 +862164041990; Email: jiang.jingjing@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: JINGJING JIANG, MD, PhD; Phone Number: 692023 +862164041990; Email: li.xiaoying@zs-hospital.sh.cn
      • Principal Investigator: Xiaoying Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dihydroartemisinin Treatment Arm; The subjects take dihydroartemisinin, 40mg tid for 90 days	Drug: Dihydroartemisinin; dihydroartemisinin 40mg tid po for 90 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of regular menses	Record of vaginal bleeding within 6 months after start taking dihydroartemisinin	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum anti-Mullerian hormone (AMH)	Serum AMH before and after 90 days of medication	90 days
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
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xiaoying Li, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Artenimol
• Other Study ID Numbers: B2020-115(2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No