Efficacy of Dihydroartemisinin for Treating PCOS

NCT06417099 | Completed Phase 2

• 1 other identifier: B2020-115(2)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Recovery of regular menses

  Record of vaginal bleeding within 6 months after start taking dihydroartemisinin

  180 days

Secondary Outcomes (3)

• Serum anti-Mullerian hormone (AMH)

  90 days

• Free androgen index (FAI)

  90 days

• Number of immature follicles

  90 days

Study Arms (1)

Dihydroartemisinin Treatment Arm

EXPERIMENTAL

The subjects take dihydroartemisinin, 40mg tid for 90 days

Drug: Dihydroartemisinin

Interventions

Dihydroartemisinin DRUG

dihydroartemisinin 40mg tid po for 90 consecutive days

Dihydroartemisinin Treatment Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

artenimol

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Xiaoying Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: May 24, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)