The Effect of Dihydroartemisinin in PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dihydroartemisinin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongshan Hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dihydroartemisinin Group
Arm Description
The subjects take Dihydroartemisinin, 40mg tid for 12 weeks
Outcomes
Primary Outcome Measures
Recovery of regular menses by questionnaire
Periodical vaginal bleeding by questionnaire
Bilateral ovary volume
Length, width and height of bilateral ovaries measured by B type ultrasound
Number of immature follicles
Total number of follicles with diameters <10 mm measured by B type ultrasound
Serum testosterone levels
Measurement of serum total testosterone
Secondary Outcome Measures
Serum anti-Mullerian hormone
Measurement of serum AMH
Sex hormone binding globulin (SHBG)
Measurement of serum SHBG
Serum dehydroepiandrosterone sulfate
Measurement of serum DHEA
Full Information
NCT ID
NCT05465135
First Posted
July 10, 2022
Last Updated
June 2, 2023
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05465135
Brief Title
The Effect of Dihydroartemisinin in PCOS
Official Title
The Evaluation of the Effect of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by a combination of genetic and environmental factors. The pathogenesis of PCOS remains unclear. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin has significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigator's previous studies found that artemisinin and its derivatives could significantly promote uncoupling protein 1 (UCP1) transcription and the conversion of white fat to brown fat. Artemisinin derivatives upregulated the levels of genes critical for brown fat differentiation and function, accompanied by enhanced mitochondrial biosynthesis, demonstrating their potential to promote white fat browning and improve metabolism in rodent models. The investigators also observed that androgen levels in drug-induced PCOS rats were reduced, when treated with artemether analogs for prophylactic and therapeutic purposes, respectively. It is believed that the two core mechanisms in the pathogenesis of PCOS are excessive androgen synthesis and insulin resistance. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both serum androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms and control or even reverse the disease progression. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
20 participants with PCOS receive dihydroartemisinin for 3 months
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dihydroartemisinin Group
Arm Type
Experimental
Arm Description
The subjects take Dihydroartemisinin, 40mg tid for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin
Intervention Description
Dihydroartemisinin 40mg three times a day for 12 consecutive weeks.
Primary Outcome Measure Information:
Title
Recovery of regular menses by questionnaire
Description
Periodical vaginal bleeding by questionnaire
Time Frame
12 weeks
Title
Bilateral ovary volume
Description
Length, width and height of bilateral ovaries measured by B type ultrasound
Time Frame
12 weeks
Title
Number of immature follicles
Description
Total number of follicles with diameters <10 mm measured by B type ultrasound
Time Frame
12 weeks
Title
Serum testosterone levels
Description
Measurement of serum total testosterone
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum anti-Mullerian hormone
Description
Measurement of serum AMH
Time Frame
12 weeks
Title
Sex hormone binding globulin (SHBG)
Description
Measurement of serum SHBG
Time Frame
12 weeks
Title
Serum dehydroepiandrosterone sulfate
Description
Measurement of serum DHEA
Time Frame
12 weeks after drug intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JINGJING JIANG, MD
Phone
+862164041990
Ext
692023
Email
jiang.jingjing@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JINGJING JIANG, MD
Phone
+862164041990
Ext
692023
Email
jiang.jingjing@zs-hospital.sh.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Dihydroartemisinin in PCOS
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