Clinical trial NCT05465135: The Effect of Dihydroartemisinin in PCOS
Official title: The Evaluation of the Effect of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 19
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 participants with PCOS receive dihydroartemisinin for 3 months
Primary purpose: TREATMENT

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.

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:

  1. 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.
  2. Polycystic ovaries: ≥12 follicles in both ovaries (diameter\<10mm), confirmed by ultrasound.
  3. 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.

Primary outcomes:
measure: Recovery of regular menses by questionnaire
timeFrame: 12 weeks
measure: Bilateral ovary volume
timeFrame: 12 weeks
measure: Number of immature follicles
timeFrame: 12 weeks
measure: Serum testosterone levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum anti-Mullerian hormone
timeFrame: 12 weeks
measure: Sex hormone binding globulin (SHBG)
timeFrame: 12 weeks
measure: Serum dehydroepiandrosterone sulfate
timeFrame: 12 weeks after drug intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Fudan University
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
References: