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

August 25, 2022 updated by: Bing He

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use Metformin for 3 months to treat PCOS
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
Drug: Metformin
Use Metformin for 3 months to treat PCOS
Experimental: Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS
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
Drug: Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets
Use Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets for 3 months to treat PCOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sex hormone binding globulin (SHBG)
Time Frame: 12 weeks
Changes in sex hormone binding globulin (SHBG)
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bing He

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

March 20, 2023

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M0741

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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