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Polycystic Ovary Syndrome (PCOS)Phase 2NCT06842524

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

A Phase 2 study testing Dihydroartemisinin in people with Polycystic Ovary Syndrome (PCOS), run by Shanghai Zhongshan Hospital at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Polycystic Ovary Syndrome (PCOS)
What is being tested?
Dihydroartemisinin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
4 sitesChina
Study dates
16 Apr 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Patients on oral contraceptives. A two-month washout period will be required prior to screening for patients on these agents. A one-month washout will be required for patients on oral cyclic progestins. Patients on depo-progestins or hormonal implants are excluded.
  • Patients with liver disease defined as ALT or AST above normal range of each participating center, or total bilirubin>30umol/L. Metabolic dysfunction-associated steatotic liver disease (MASLD) with normal ALT and AST can be included.
  • Patients with anemia (Hemoglobin < 12 g/dL) or neutropenia (neutrocyte <1.8×10^9/L).
  • Patients with renal disease defined as serum creatinine> 115umol/L.
  • Patients diagnosed with other endocrine diseases that are known to cause secondary polycystic ovary morphology, e.g., Cushing's syndrome, hyperprolactinemia, congenital adrenal hyperplasia (21-hydroxylase deficiency or other enzyme deficiency), hypothyroidism, etc.
  • Patients diagnosed with Type 1 or Type 2 diabetes.
Show all 10Show fewer
  • Patients with known heart disease, like heart failure, atrial fibrillation, coronary heart disease, etc.
  • Patients with a history of any type of cancer.
  • Patients taking other medications known to affect reproductive function or metabolism. These medications include GnRH agonists and antagonists, antiandrogens, gonadotropins, GLP-1 receptor agonist, SGLT2i, metformin and thiazolidinediones. The washout period on all these medications will be two months.
  • Patients who have undergone a bariatric surgery procedure within the past 12 months.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liangshan Mu, MD, PhD contact

86-021-64041990

mu.liangshan@zs-hospital.sh.cn

China4 sites, 4 recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

    Liangshan Mu, MD, PhD, 86-021-64041990, mu.liangshan@zs-hospital.sh.cn

    Xi Dong, MD

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Xiaojing Lin, MD, 86-0577-55579999, llxxjj12@163.com

    Haiyan Yang, MD

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Xin Zheng, MD, 86-0592-2132222, zx2001528@163.com

    Changqin Liu, MD

    Recruiting

  • Women and Children's Hospital, School of Medicine, Xiamen University

    Xiamen, Fujian, 361003

    Rongjuan Chen, MD, 86-0592-2662020, crj19910422@163.com

    Guiquan Wang, MD

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Dihydroartemisinin, Placebo
Keywords
Polycystic Ovary Syndrome, Dihydroartemisinin
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DihydroartemisininDrug

    Dihydroartemisinin tablets 40mg tid po for 90 days

  • PlaceboDrug

    Identical placebo tid for 90 days

Study groups in NCT06842524
Study groupRoleWhat they receive
Dihydroartemisinin ArmActive comparatorDihydroartemisinin tablets 40mg tid for 90 days
Receives: Drug: Dihydroartemisinin
Placebo ArmPlacebo comparatorIdential placebo tid for 90 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of a regular menstrual cycle

    The occurrence of a regular menstrual cycle is defined as at least three consecutive spontaneous vaginal bleedings lasting for 2-7 days, with intervals between the start of each cycle of 21 and 35 days (inclusive), during the 26-week period after initiating treatment.

    Measured: From the start of treatment to the end of follow-up at 26 weeks

Secondary outcomes (7)

  1. The presence of a dominant follicle

    This will be verified by transvaginal/transanal ultrasound before predicted ovulation, or testing serum progesterone in the predicted mid-luteal phase (A progesterone level>16nmol/L or 5ng/ml is suggestive of ovulation) in those with at least two consecutive spontaneous bleedings.

    Measured: From the start of treatment to the end of follow-up at 26 weeks

  2. The number of bilateral antral follicles

    This will be measured by transvaginal/transanal ultrasound before and immediately after 90-day treatment. Antral follicles are defined as follicles measuring 2-9 mm in diameter in the ovary.

    Measured: Before and immediately after 90-day treatment

  3. Serum AMH

    This will be measured before and immediately after 90-day treatment.

    Measured: Before and immediately after 90-day treatment

  4. Serum total testosterone

    This will be measured before and immediately after 90-day treatment.

    Measured: Before and immediately after 90-day treatment

  5. Serum sex hormone binding globulin (SHBG)

    This will be measured before and immediately after 90-day treatment.

    Measured: Before and immediately after 90-day treatment

  6. free androgen index (FAI)

    This will be calculated before and immediately after 90-day treatment. FAI is calculated from measurable values for total testosterone and SHBG, using the following equation: FAI = (Total testosterone in nmol/L / SHBG in nmol/L) × 100.

    Measured: Before and immediately after 90-day treatment

  7. HOMA-IR

    HOMA-IR will be calculated before and immediately after 90-day treatment. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5.

    Measured: Before and immediately after 90-day treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start16 Apr 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842524
Sponsor's protocol ID
B2024-417(2)
Status last verified
Apr 2025
First submitted
19 Feb 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • Mu L, Shen Y, Wang G, Liu C, Yang H, Li W, Mol BW, Li X, Dong X, Jiang J. Dihydroartemisinin for the treatment of polycystic ovary syndrome: study protocol for a multi-centre placebo-controlled randomised clinical trial. BMJ Open. 2026 Jun 19;16(6):e108980. doi: 10.1136/bmjopen-2025-108980.

    PubMed 42320967

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dihydroartemisinin in people with Polycystic Ovary Syndrome (PCOS), run by Shanghai Zhongshan Hospital at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liangshan Mu, MD, PhD (86-021-64041990, mu.liangshan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of a regular menstrual cycle (time frame: From the start of treatment to the end of follow-up at 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06842524, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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