Efficacy of Dihydroartemisinin for Treating PCOS

Last updated: April 17, 2025
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Completed

Phase

2

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Dihydroartemisinin

Clinical Study ID

NCT06417099
B2020-115(2)
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 peryear; > 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

Exclusion Criteria:

  • Pregnancy.

  • Patients with other endocrine diseases that can cause secondary PCOS, including butnot limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing'ssyndrome, etc.

  • Patients with other serious diseases affecting heart, liver, kidney, or other majororgans.

  • Patients with any type of cancer.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Dihydroartemisinin
Phase: 2
Study Start date:
May 24, 2024
Estimated Completion Date:
March 30, 2025

Study 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.

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.