Effects of Pioglitazone Combined With Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients.

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Pioglitazone Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients With Hyperandrogenemia.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05519813
• Other study ID #: M0741
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: August 2022
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 20, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin
Use Metformin for 3 months to treat PCOS
• Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets
Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Bing He

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sex hormone binding globulin (SHBG)	Changes in sex hormone binding globulin (SHBG)	12 weeks
Secondary	Changes in free testosterone (FT)	Changes in free testosterone (FT)	12 weeks
Secondary	Changes in Luteinizing Hormone (LH)	Changes in Luteinizing Hormone (LH)	12 weeks
Secondary	Changes in follicle stimulating hormone (FSH)	Changes in follicle stimulating hormone (FSH)	12 weeks
Secondary	Changes in total testosterone (TT)	Changes in total testosterone (TT)	12 weeks
Secondary	Changes in dehydroepiandrosterone sulfate (DHEAS)	Changes in dehydroepiandrosterone sulfate (DHEAS)	12 weeks
Secondary	Changes in anti-müllerian hormone (AMH)	Changes in anti-müllerian hormone (AMH)	12 weeks
Secondary	Changes in progesterone (Prog)	Changes in progesterone (Prog)	12 weeks
Secondary	Changes in prolactin (PRL)	Changes in prolactin (PRL)	12 weeks
Secondary	Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)	glucose obtained at 0 minutes during the OGTT.	12 weeks
Secondary	Changes in frequency of menstrual cycle	Changes in frequency of menstrual cycle	12 weeks
Secondary	Change in Acne severity score	Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.	12 weeks
Secondary	Change in Ferriman-Gallwey score	Change in Ferriman-Gallwey score#the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.	12 weeks
Secondary	Change in waist circumference(WC)	Change in waist circumference(WC)	12 weeks