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Status unknownNCT05519813Updated Aug 29, 2022

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

A Phase 4 interventional study of Metformin and Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets in Polycystic Ovary Syndrome, sponsored by Bing He. Status unknown at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by Bing He · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2022, registered Apr 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Bing He is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugMetformin

    Use Metformin for 3 months to treat PCOS

  • DrugPioglitazone Hydrochloride And Metformin Hydrochloride Tablets

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

06

What researchers measure

Primary outcomes

  1. Changes in sex hormone binding globulin (SHBG)

    Changes in sex hormone binding globulin (SHBG)

    Time frame: 12 weeks

Secondary outcomes

  1. Changes in free testosterone (FT)

    Changes in free testosterone (FT)

    Time frame: 12 weeks

  2. Changes in Luteinizing Hormone (LH)

    Changes in Luteinizing Hormone (LH)

    Time frame: 12 weeks

  3. Changes in follicle stimulating hormone (FSH)

    Changes in follicle stimulating hormone (FSH)

    Time frame: 12 weeks

  4. Changes in total testosterone (TT)

    Changes in total testosterone (TT)

    Time frame: 12 weeks

  5. Changes in dehydroepiandrosterone sulfate (DHEAS)

    Changes in dehydroepiandrosterone sulfate (DHEAS)

    Time frame: 12 weeks

  6. Changes in anti-müllerian hormone (AMH)

    Changes in anti-müllerian hormone (AMH)

    Time frame: 12 weeks

  7. Changes in progesterone (Prog)

    Changes in progesterone (Prog)

    Time frame: 12 weeks

  8. Changes in prolactin (PRL)

    Changes in prolactin (PRL)

    Time frame: 12 weeks

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

    glucose obtained at 0 minutes during the OGTT.

    Time frame: 12 weeks

  10. Changes in frequency of menstrual cycle

    Changes in frequency of menstrual cycle

    Time frame: 12 weeks

  11. 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.

    Time frame: 12 weeks

  12. 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.

    Time frame: 12 weeks

  13. Change in waist circumference(WC)

    Change in waist circumference(WC)

    Time frame: 12 weeks

07

Study locations

1 site
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning 110004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05519813
Lead sponsor
Bing He
Responsible party
Bing He (Professor, Shengjing Hospital) — Sponsor-investigator
First posted
Aug 29, 2022
Start date
Jan 1, 2022
Primary completion
Jan 1, 2023 (estimated)
Completion
Mar 20, 2023 (estimated)
Last update
Aug 29, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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