Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder affecting women of reproductive age, with a prevalence of 10 to 13%. PCOS is characterized by irregular menstrual cylcles/ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. For infertile patients seeking ovulation induction, letrozole is the drug of first choice. For PCOS patients not seeking pregnancy, there exists a variety of treatments to alleviate symptoms. It has been demonstrated that artemisinin derivatives can promote energy expenditures and insulin sensitivity by activating thermogenic adipocytes, thereby protecting against diet-induced obesity and metabolic disorders in rodents. Recently, we showed in a single arm pilot study including 19 PCOS-patients, that dihydroartemisinin ameliorated hyperandrogenemia reduced antral follicle count and normalized menstrual cycles. Based on these findings, we aim to evaluate the efficacy of dihydroartemisinin in women with PCOS in a placebo controlled randomized clinical trial. The primary outcome is return of regular menstrual cycles within 6 months after start of treatment, with antral follicle count and metabolic profile being secondary outcomes. The results will potentially impact the standard of care for patients diagnosed with PCOS.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Women with PCOS defined as having irregular menstrual cycles and hyperandrogenism. Irregular menstrual cycles are defined as \< 21 or \> 35 days or \< 8 cycles per year. Hyperandrogenism refers to either hyperandrogenemia or hirsutism. Hyperandrogenemia will be defined as an elevated total testosterone \>1.67 nmol/L measured by Elecsys Testosterone II (Roche Diagnostics). Hirsutism is determined by a modified Ferriman-Gallwey Score \>4 at screening exam.

• Body Mass Index (BMI) between 18.5 and 28 kg/M2

• Negative pregnancy test

• No plan for pregnancy in the coming 6 months

Locations
Other Locations
China
Zhongshan Hospital Fudan University
RECRUITING
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Women and Children's Hospital, School of Medicine, Xiamen University
RECRUITING
Xiamen
Contact Information
Primary
Liangshan Mu, MD, PhD
mu.liangshan@zs-hospital.sh.cn
86-021-64041990
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: Dihydroartemisinin Arm
Dihydroartemisinin tablets 40mg tid for 90 days
Placebo_comparator: Placebo Arm
Idential placebo tid for 90 days
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov