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Clinical and metabolic effects of dianette plus metformin and metformin only in women with polycystic ovary syndrome and metabolic disorders: a randomized controlled trial

Clinical and metabolic effects of dianette plus metformin and metformin only in women with polycystic ovary syndrome and metabolic disorders: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002934
Enrollment
Unknown
Registered
2012-12-29
Start date
2012-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

polycystic ovary syndrome

Interventions

A:Dianette (1pill, po, 6months) and metformin (500mg, t.i.d, 6 months)
B:metformin (500mg, t.i.d, 6 months)

Sponsors

West China Second University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women diagnosed of PCOS; 2. BMI>=25 or fasting insulin>=20uu/ml or HOMA-IR>2.77

Exclusion criteria

Exclusion criteria: 1. Women who have the contraindication of oral contraceptive; 2. Women who have specified coexisting disease affecting the glycometabolism and lipid metabolism; 3. Women who receive hormonal therapy in the last three months; 4. Heavy smokers(>10 cigarettes/day); 5. BMI>35 kg/m2.

Design outcomes

Primary

MeasureTime frame
Insulin resistance;blood fat;Obesity related indexes;hyperandrogenic clinical manifestation;

Secondary

MeasureTime frame
sex hormone;blood pressure;

Countries

China

Contacts

Public ContactWei HUANG
xiaoqiuqiuqiuqiuqi@163.com+86 28 85501346

Outcome results

None listed

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