Effects of low-dose spironolactone combined with metformin or either drug alone on insulin resistance in patients with polycystic ovary syndrome: a pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040178

Enrollment

Unknown

Registered

2020-11-24

Start date

2014-01-01

Completion date

Unknown

Last updated

2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome

Interventions

metformin group:metformin 1500 mg/d 12weeks

spironolactone group :spironolactone 40 mg/d 12weeks

metformin + spironolactone group.:metformin 1500 mg/d and spironolactone 40 mg/d. 12weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. aged >18 years; 2. history of sexual life; 3. agreed to use barrier contraception within 12 weeks.

Exclusion criteria

Exclusion criteria: 1. other endocrine diseases such as hyperprolactinemia and congenital adrenal hyperplasia (CAH), or hyperprolactinemia and other endocrine diseases that led to hyperandrogenism, such as Cushing's syndrome, CAH, and androgen-secreting tumors; 2. patients with immune diseases, cancer, type 1 diabetes, or history of type 2 diabetes; 3. medications within 12 weeks, including cortisol, antidepressants, hypoglycemic agents, hormonal contraceptives, ovulation-inducing drugs, or other drugs that affect the metabolism of glycolipids and sex hormones; 4. pregnant or lactating women within the recent 6 months or those with pregnancy plan within 3 months; 5. patients with speech impairment or those with disabilities who cannot understand the experimental requirements; 6. patients with severe organ failure such as liver or renal function, or mental disorders; 7. patients with immunodeficiency or HIV infection; 8. history of drug abuse and alcohol dependence in the past 5 years; 9. history of pancreatitis or pancreatectomy; 10. participated in any clinical trials within 3 months.

Design outcomes

Primary

Measure	Time frame
luteinizing hormone (LH),;follicle-stimulating hormone (FSH);total cholesterol (TC);total testosterone (TT).;blood glucose;insulin (INS) levels;	—

Secondary

Measure	Time frame
sex hormone-binding globulin (SHBG);height,;weight;waist;hip circumference;blood pressure.;menstrual status;	—

Countries

China

Contacts

Public ContactTao Long

Endocrinology department, The Fifth Affiliated Hospital of Guangzhou Medical University

2336889@163.com+86 15626214516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026