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Effects of different treatment on lipid metabolism in patients with polycystic ovary syndrome

Effects of different treatment on lipid metabolism in patients with polycystic ovary syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039759
Enrollment
Unknown
Registered
2020-11-08
Start date
2020-11-06
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight or obese polycystic ovary syndrome

Interventions

Group A:Dydrogesterone
Group B:Drospirenone and Ethinylestradiol Tablets (II)

Sponsors

Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent; 2. Chinese, female of reproductive age between 16 and 40 years old; 3. Overweight patients with 28kg/m2 > BMI >= 24kg/m2 and WC >= 80cm; 4. PCOS was diagnosed according to Guidelines formulated by the Chinese Medical Association in 2018: (1) Rare ovulation or anovulation: clinical manifestations are amenorrhea, oligomenorrhea, menarche 2-3 years can not establish regular menstruation and basic body temperature is uniphase. Sometimes menstruation is regular but no ovulation; (2) Clinical manifestations of hyperandrogen and hyperandrogenemia: clinical manifestations include acne and hypertrichosis; (3) Ovarian polycystic changes: B ultrasound examination showed that the diameter of one or both sides of the ovary 2-9 mm follicles >= 12 and/or ovarian volume >= 10cm3. Two of the above three conditions were consistent, and other diseases causing high androgen, such as congenital adrenal cortical hyperplasia, Cushing syndrome and androgen-secreting tumors, will be excluded. PCOS can be diagnosed. 5. Application of Dydrogesterone Tablets or Drospirenone and Ethinylestradiol Tablets (II) treatment.

Exclusion criteria

Exclusion criteria: 1. Drug contraindication; 2. Smokers or former smokers; 3. Abnormal uterine bleeding outside PCOS, such as endometriosis, adenomyosis or unexplained abnormal uterine bleeding; 4. Pregnancy or breastfeeding; 5. Have a family history of thrombosis; 6. People with high risk of venous or arterial thrombosis, patients with multiple risk factors or with higher severity of individual risk factors should consider the possibility of a synergistic increase in thrombosis risk. This increased risk may be greater than the simple cumulative risk factor; 7. Alcohol, drug abuse or drug exposure period; 8. Suffering from serious genetic, physical or mental diseases; 9. Hormone drugs or ovulation induction therapy were used in the first 3 months; 10. Participated in other clinical research in the past 3 months; 11. Suffer from reproductively transmitted diseases.

Design outcomes

Primary

MeasureTime frame
TC;TG;

Secondary

MeasureTime frame
body weight;WHR;LDL-C;HDL-C;FSH;LH;E2;T;P;FT;TT;PRL;AMH;SHGB;FPG;liver function test;Renal function test;B-mode ultrasonography of vagina;Bleeding pattern;FPG;FINS;

Countries

China

Contacts

Public ContactXiangyan Ruan

Beijing Obstetrics & Gynecology Hospital, Capital Medical university

ruanxiangyan@163.com+86 13011215678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026