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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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