Clinical trial NCT05519813: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in sex hormone binding globulin (SHBG)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in free testosterone (FT)
timeFrame: 12 weeks
measure: Changes in Luteinizing Hormone (LH)
timeFrame: 12 weeks
measure: Changes in follicle stimulating hormone (FSH)
timeFrame: 12 weeks
measure: Changes in total testosterone (TT)
timeFrame: 12 weeks
measure: Changes in dehydroepiandrosterone sulfate (DHEAS)
timeFrame: 12 weeks
measure: Changes in anti-müllerian hormone (AMH)
timeFrame: 12 weeks
measure: Changes in progesterone (Prog)
timeFrame: 12 weeks
measure: Changes in prolactin (PRL)
timeFrame: 12 weeks
measure: Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
timeFrame: 12 weeks
measure: Changes in frequency of menstrual cycle
timeFrame: 12 weeks
measure: Change in Acne severity score
timeFrame: 12 weeks
measure: Change in Ferriman-Gallwey score
timeFrame: 12 weeks
measure: Change in waist circumference(WC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References: