Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status

Active

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Metformin

Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
BMI<24 kg/m2
No pregnant plan in recent 6 months
Written consent for participation in the study

Exclusion Criteria:

type 1 or type 2 diabetes mellitus
Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Serious systemic disease or malignant tumor
History of pancreatitis (chronic, acute or recurrent)
Body weight change ≥10% at 3 months before treatment
Used oral contraceptives or sex hormone drugs in the past 1 month
Used oral glucocorticoids in the past 1 month
Substance (alcohol or drug) abuse or dependence within 3 months
Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2)
Increase of transaminases up to < 2.5 times of upper limit of normal value
Have a history of thromboembolic disease or thrombotic tendency
Subjects in pregnant or lactating or within 1 year after delivery
Subjects have an allergic history to the drugs used in the study
Subjects have participated in other clinical researches of medicine within
1 month prior to randomization
Use of metformin, pioglitazone, or pioglitazone combined with metformin within 30 days before screening

Sites / Locations

Shengjing Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Use Metformin for 3 months to treat PCOS

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

Arm Description

Active Comparator: Metformin (BMI<24) Subjects: PCOS patients whoseBMI<24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months

Active Comparator: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets (BMI<24) Subjects: PCOS patients whoseBMI<24 Drug: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets Generic name: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets Dosage form: 15mg/500mg Dosage: 2 tablets/day Frequency: one tablet twice a day Duration: 3 months

Outcomes

Primary Outcome Measures

Changes in sex hormone binding globulin (SHBG)

Secondary Outcome Measures

Changes in free testosterone (FT)

Changes in Luteinizing Hormone (LH)

Changes in follicle stimulating hormone (FSH)

Changes in total testosterone (TT)

Changes in dehydroepiandrosterone sulfate (DHEAS)

Changes in anti-müllerian hormone (AMH)

Changes in progesterone (Prog)

Changes in prolactin (PRL)

Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)

glucose obtained at 0 minutes during the OGTT.

Changes in frequency of menstrual cycle

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.

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.

Change in waist circumference(WC)

Full Information

NCT ID

NCT05519813

First Posted

April 13, 2022

Last Updated

August 25, 2022

Sponsor

Bing He

1. Study Identification

Unique Protocol Identification Number

NCT05519813

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

March 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bing He

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Use Metformin for 3 months to treat PCOS

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Use Metformin for 3 months to treat PCOS

Intervention Type

Drug

Intervention Name(s)

Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in sex hormone binding globulin (SHBG)

Description

Changes in sex hormone binding globulin (SHBG)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Changes in free testosterone (FT)

Description

Changes in free testosterone (FT)

Time Frame

12 weeks

Title

Changes in Luteinizing Hormone (LH)

Description

Changes in Luteinizing Hormone (LH)

Time Frame

12 weeks

Title

Changes in follicle stimulating hormone (FSH)

Description

Changes in follicle stimulating hormone (FSH)

Time Frame

12 weeks

Title

Changes in total testosterone (TT)

Description

Changes in total testosterone (TT)

Time Frame

12 weeks

Title

Changes in dehydroepiandrosterone sulfate (DHEAS)

Description

Changes in dehydroepiandrosterone sulfate (DHEAS)

Time Frame

12 weeks

Title

Changes in anti-müllerian hormone (AMH)

Description

Changes in anti-müllerian hormone (AMH)

Time Frame

12 weeks

Title

Changes in progesterone (Prog)

Description

Changes in progesterone (Prog)

Time Frame

12 weeks

Title

Changes in prolactin (PRL)

Description

Changes in prolactin (PRL)

Time Frame

12 weeks

Title

Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)

Description

glucose obtained at 0 minutes during the OGTT.

Time Frame

12 weeks

Title

Changes in frequency of menstrual cycle

Description

Changes in frequency of menstrual cycle

Time Frame

12 weeks

Title

Change in Acne severity score

Description

Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.

Time Frame

12 weeks

Title

Change in Ferriman-Gallwey score

Description

Change in Ferriman-Gallwey score#the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.

Time Frame

12 weeks

Title

Change in waist circumference(WC)

Description

Change in waist circumference(WC)

Time Frame

12 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria BMI<24 kg/m2 No pregnant plan in recent 6 months Written consent for participation in the study Exclusion Criteria: type 1 or type 2 diabetes mellitus Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Serious systemic disease or malignant tumor History of pancreatitis (chronic, acute or recurrent) Body weight change ≥10% at 3 months before treatment Used oral contraceptives or sex hormone drugs in the past 1 month Used oral glucocorticoids in the past 1 month Substance (alcohol or drug) abuse or dependence within 3 months Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d) Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2) Increase of transaminases up to < 2.5 times of upper limit of normal value Have a history of thromboembolic disease or thrombotic tendency Subjects in pregnant or lactating or within 1 year after delivery Subjects have an allergic history to the drugs used in the study Subjects have participated in other clinical researches of medicine within 1 month prior to randomization Use of metformin, pioglitazone, or pioglitazone combined with metformin within 30 days before screening

Facility Information:

Facility Name

Shengjing Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110004

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs