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Trial Title:
Effects of Pioglitazone Combined With Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients.
NCT ID:
NCT05519813
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Metformin
Pioglitazone
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Metformin
Description:
Use Metformin for 3 months to treat PCOS
Arm group label:
Use Metformin for 3 months to treat PCOS
Intervention type:
Drug
Intervention name:
Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets
Description:
Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat
PCOS
Arm group label:
Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS
Summary:
To study the effects of pioglitazone combined with metformin and metformin on gonadal and
metabolic profiles in PCOS patients with BMI < 24 in China. 60 cases of nonobese PCOS
patients were collected from Shengjing hospital. The intervention period was 3 months
after intervention with met or met + ph. To evaluate the improvement of met or met + ph
in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference,
menstruation, hairiness and acne in PCOS patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
2. BMI<24 kg/m2
3. No pregnant plan in recent 6 months
4. Written consent for participation in the study
Exclusion Criteria:
1. type 1 or type 2 diabetes mellitus
2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor,
androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and
hyperprolactinemia
3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or
Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Serious systemic disease or malignant tumor
5. History of pancreatitis (chronic, acute or recurrent)
6. Body weight change ≥10% at 3 months before treatment
7. Used oral contraceptives or sex hormone drugs in the past 1 month
8. Used oral glucocorticoids in the past 1 month
9. Substance (alcohol or drug) abuse or dependence within 3 months
10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers
(>10g/d)
11. Subjects have a severe systemic disease, such as cardiovascular system, Renal
impairment (eGFR<60ml/min/1.73m2)
12. Increase of transaminases up to < 2.5 times of upper limit of normal value
13. Have a history of thromboembolic disease or thrombotic tendency
14. Subjects in pregnant or lactating or within 1 year after delivery
15. Subjects have an allergic history to the drugs used in the study
16. Subjects have participated in other clinical researches of medicine within
1 month prior to randomization
17. Use of metformin, pioglitazone, or pioglitazone combined with metformin within 30
days before screening
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Start date:
January 1, 2022
Completion date:
March 20, 2023
Lead sponsor:
Agency:
Bing He
Agency class:
Other
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519813
