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A controlled, prospective clinical study for evaluating the efficacy of orlistat combined with Drospirenone and Ethinylestradiol Tablets (II) in the treatment of overweight or obese patients with polycystic ovary syndrome

A controlled, prospective clinical study for evaluating the efficacy of orlistat combined with Drospirenone and Ethinylestradiol Tablets (II) in the treatment of overweight or obese patients with polycystic ovary syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020986
Enrollment
Unknown
Registered
2019-01-24
Start date
2018-05-01
Completion date
Unknown
Last updated
2019-01-28

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 1:Drospirenone and Ethinylestradiol Tablets(II)
Group 2:orlistat combined with Drospirenone and Ethinylestradiol Tablets(II)

Sponsors

Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Chinese, female of reproductive age between 16 and 40 years old; 2. Overweight or obese patients with BMI=24kg/m2 and WC=80cm; 3. PCOS was diagnosed according to Rotterdam standard 2003. (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.

Exclusion criteria

Exclusion criteria: 1. Hormone drugs or ovulation induction therapy were used in the first 3 months; 2. Suffering from a reproductive transmitted disease; 3. Suffering from serious genetic, physical or mental diseases; 4. One party is exposed to teratogenic rays, poisons and drugs and is in effect; 5. Endometriosis and adenomyosis; 6. Allergic to any one of the ingredients of all tested drugs; 7. Drug contraindication: (1) peptic ulcer or malabsorption syndrome; (2) History of recurrent gallstones and kidney stones; (3) Had been diagnosed as postoperative intestinal adhesion; (4) History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident); 8. Liver function index exceeds normal value more than 2 times; 9. Malignant tumor patients; 10. A history of pancreatitis; 11. Receiving other drugs in the past 3 months.

Design outcomes

Primary

MeasureTime frame
FSH;LH;E2;T;TSH;Insulin;serum lipid level;blood glucose level;liver function test;Renal function test;Visceral fat area;Subcutaneous fat area;

Countries

China

Contacts

Public ContactXiangyan Ruan

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

ruanxiangyan@126.com+86 13011215678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026