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Trial Title:
Efficacy of Dihydroartemisinin for Treating PCOS
NCT ID:
NCT06417099
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Artenimol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dihydroartemisinin
Description:
dihydroartemisinin 40mg tid po for 90 consecutive days
Arm group label:
Dihydroartemisinin Treatment Arm
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
JINGJING JIANG, MD, PhD
Phone:
+862164041990
Phone ext:
692023
Email:
li.xiaoying@zs-hospital.sh.cn
Investigator:
Last name:
Xiaoying Li, MD
Email:
Principal Investigator
Start date:
May 24, 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06417099
