Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
ConditionPolycystic Ovary Syndrome (PCOS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorShanghai Zhongshan Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dihydroartemisinin
DrugDihydroartemisinin tablets 40mg tid po for 90 days
Placebo
DrugIdentical placebo tid for 90 days
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Dihydroartemisinin ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
From the start of treatment to the end of follow-up at 26 weeksSecondary outcomes
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.
Time frame
From the start of treatment to the end of follow-up at 26 weeks2
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.
Time frame
Before and immediately after 90-day treatment3
Serum AMH
This will be measured before and immediately after 90-day treatment.
Time frame
Before and immediately after 90-day treatment4
Serum total testosterone
This will be measured before and immediately after 90-day treatment.
Time frame
Before and immediately after 90-day treatmentSponsors and contacts
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Source ClinicalTrials.gov