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NCT Number: NCT06417099

Efficacy of Dihydroartemisinin for Treating PCOS

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle
  • Polycystic ovaries: ≥12 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound.
  • 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.

Treatment and study plan

Dihydroartemisinin

Drug

dihydroartemisinin 40mg tid po for 90 consecutive days

Primary outcomes

  1. Recovery of regular menses

    Time frame: 180 days

    Record of vaginal bleeding within 6 months after start taking dihydroartemisinin

Secondary outcomes

  1. Serum anti-Mullerian hormone (AMH)

    Time frame: 90 days

    Serum AMH before and after 90 days of medication

  2. Free androgen index (FAI)

    Time frame: 90 days

    FAI (Total testosterone in nmol/L / SHBG in nmol/L X 100) before and after 90 days of medication

  3. Number of immature follicles

    Time frame: 90 days

    Total number of immature follicles measuring 2-9 mm in diameter on ultrasound before and after 90 days of medication

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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