The Effect of Dihydroartemisinin in PCOS

NCT05465135 | Completed Phase 4

• 1 other identifier: B2020-115R
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin also has some significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigators' previous studies discovered that Artemisinin dramatically reduced serum androgen levels and improved poly-cystic ovary syndrome(PCOS) in animals. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

• Recovery of regular menses by questionnaire

  Periodical vaginal bleeding by questionnaire

  12 weeks

• Bilateral ovary volume

  Length, width and height of bilateral ovaries measured by B type ultrasound

  12 weeks

• Number of immature follicles

  Total number of follicles with diameters \<10 mm measured by B type ultrasound

  12 weeks

• Serum testosterone levels

  Measurement of serum total testosterone

  12 weeks

Secondary Outcomes (3)

• Serum anti-Mullerian hormone

  12 weeks

• Sex hormone binding globulin (SHBG)

  12 weeks

• Serum dehydroepiandrosterone sulfate

  12 weeks after drug intervention

Study Arms (1)

Dihydroartemisinin Group

EXPERIMENTAL

The subjects take Dihydroartemisinin, 40mg tid for 12 weeks

Drug: Dihydroartemisinin

Interventions

Dihydroartemisinin DRUG

Dihydroartemisinin 40mg three times a day for 12 consecutive weeks.

Dihydroartemisinin Group

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI 23-30kg/M2
• No plan for pregnancy in the coming 6 months
• Newly diagnosed PCOS, or PCOS without any medication for the past three months.
• Patients should meet all the three following criteria:
• Oligomenorrhea or amenorrhea: Oligomenorrhea is defined as more than 35 days between menstrual periods and less than 8 menstrual bleedings in the past year; amenorrhea is defined as more than 90 days between two menstrual bleedings.
• Polycystic ovaries: ≥12 follicles in both ovaries (diameter\<10mm), confirmed by ultrasound.
• Elevated androgen levels: testosterone\>1.67 nmol/L.

You may not qualify if:

• Previously treated with steroids or other medications for PCOS in the past 3 months.
• Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.
• Pregnancy.
• 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, 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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 20 participants with PCOS receive dihydroartemisinin for 3 months

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 19, 2022
• Study Start: July 1, 2022
• Primary Completion: March 23, 2023
• Study Completion: April 23, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)