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Comparison of the efficacy and safety of Diane-35 and Drospirenone and Ethinylestradiol Tablets (II) in the treatment of polycystic ovary syndrome: a randomized controlled trial

Comparison of weight loss in patients with polycystic ovary syndrome of glucophage and liraglutide monotherapy or combination treatment: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021593
Enrollment
Unknown
Registered
2019-02-28
Start date
2019-03-04
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Polycystic ovarian syndrome

Interventions

A:Diane-35 (2mg ciproterone acetate + 0.035mg ethinylestradiol) for 6 months
B:Drospirenone and Ethinylestradiol Tablets (II)(3mg spironetone + 0.002mg ethinylestradiol) for 6 months

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. meet the 2003 Rotterdam diagnostic criteria: (1) patients with rare ovulation or even no ovulation; (2) clinical symptoms or biochemical manifestations of patients with hyperandrogenemia; (3) polycystic changes of the ovary can be seen on abdominal color doppler ultrasound (vaginal color doppler ultrasound shows that one or both ovaries contain more than 12 follicles with a diameter of 2-9mm); A diagnosis can be made if two of the above three criteria are met. 2. aged = 18 years; 3. women of childbearing age with no childbearing requirement in the next year.

Exclusion criteria

Exclusion criteria: 1. androgen elevation caused by other reasons; 2. those who are known to be allergic to relevant drugs; 3. renal insufficiency; 4. benign and malignant liver tumors or liver diseases; 5. hypoadrenal function; 6. undiagnosed abnormal uterine bleeding; 7. have or have had breast cancer or other estrogen or progesterone sensitive cancers; 8. increased risk of arterial or venous thromboembolic disease: (1) smoking and age >35; (2) present or past deep venous thrombosis or pulmonary embolism; (3) Cerebrovascular diseases; (4) Coronary heart disease; (5) thrombotic valvular heart disease or heart rhythm disease; (6) genetic or acquired hypercoagulant disease; Uncontrolled hypertension; (7) diabetes with vascular disease; (8) headache with focal neurological symptoms; 9. have used any hypoglycemic, lipid-lowering or blood pressure-lowering drugs in the past 3 months; 10. have used compound oral contraceptives.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms of hyperandrogenemia (FG score, acne score);Biochemical indicators of hyperandrogenemia;menstrual cycle;

Secondary

MeasureTime frame
BMI;Waist-to-hip ratio;Percentage of body fat;Visceral fat area;Visceral fat area;Blood pressure;lipid metabolism;carbohydrate metabolism;Gynecological B ultrasonic;

Countries

China

Contacts

Public ContactYi Liu

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

liqun94@163.com+86 13971038710

Outcome results

None listed

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