## Protocol Section
### Identification Module
**NCT ID:** NCT06417099

**Brief Title:** Efficacy of Dihydroartemisinin for Treating PCOS

**Official Title:** Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome

#### Organization Study ID Info
**ID:** B2020-115(2)
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Zhongshan Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Polycystic Ovary Syndrome

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The subjects take dihydroartemisinin, 40mg tid for 90 days

**Intervention Names:**

- Drug: Dihydroartemisinin

**Label:** Dihydroartemisinin Treatment Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dihydroartemisinin Treatment Arm

**Description:** dihydroartemisinin 40mg tid po for 90 consecutive days

**Name:** Dihydroartemisinin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Record of vaginal bleeding within 6 months after start taking dihydroartemisinin

**Measure:** Recovery of regular menses

**Time Frame:** 180 days

#### Secondary Outcomes

**Description:** Serum AMH before and after 90 days of medication

**Measure:** Serum anti-Mullerian hormone (AMH)

**Time Frame:** 90 days

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

**Measure:** Free androgen index (FAI)

**Time Frame:** 90 days

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

**Measure:** Number of immature follicles

**Time Frame:** 90 days

### Eligibility Module

**Eligibility Criteria:** 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:

  1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle
  2. Polycystic ovaries: ≥12 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound.
  3. 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.

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jiang.jingjing@zs-hospital.sh.cn

**Name:** JINGJING JIANG, MD, PhD

**Phone:** +862164041990

**Phone Ext:** 692023

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** li.xiaoying@zs-hospital.sh.cn

- **Name:** JINGJING JIANG, MD, PhD

- **Phone:** +862164041990

- **Phone Ext:** 692023

- **Role:** CONTACT

***Contact 2:***

- **Name:** Xiaoying Li, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Zhongshan Hospital, Fudan University

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200032

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Xiaoying Li, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010048

- Term: Ovarian Cysts

- ID: D000003560

- Term: Cysts

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M13970

- Name: Polycystic Ovary Syndrome

- Relevance: HIGH

- As Found: Polycystic Ovary Syndrome

- ID: M6765

- Name: Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M12971

- Name: Ovarian Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011085

- Term: Polycystic Ovary Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000000962

- Term: Antimalarials

- ID: D000000981

- Term: Antiprotozoal Agents

- ID: D000000977

- Term: Antiparasitic Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M189432

- Name: Artenimol

- Relevance: HIGH

- As Found: Carbon dioxide

- ID: M4280

- Name: Antimalarials

- Relevance: LOW

- As Found: Unknown

- ID: M4298

- Name: Antiprotozoal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000039060

- Term: Artenimol

### Misc Info Module

- Version Holder: 2024-05-31
