The reproductive and metabolic effect of rosiglitazone on Chinese women with polycystic ovarian syndrome--a double-blind randomized placebo-controlled study

Fertil Steril. 2011 Aug;96(2):445-451.e1. doi: 10.1016/j.fertnstert.2011.05.085. Epub 2011 Jul 1.

Abstract

Objective: To investigate whether an insulin sensitizer has any effect on amenorrhea and clinical and biochemical hyperandrogenism in Chinese women with polycystic ovarian syndrome (PCOS).

Design: Randomized controlled double-blind trial.

Setting: A tertiary referral center, Hong Kong.

Patient(s): Chinese women who fulfilled the Rotterdam criteria of PCOS (n = 70).

Intervention(s): Rosiglitazone 4 mg daily for the first month followed by 4 mg twice daily for 11 months.

Main outcome measure(s): Menstrual status as well as clinical and biochemical hyperandrogenism.

Result(s): There is a significantly higher rate of regular menses among the treatment arm (16 [50.0%] of 32 vs 4 [11.8%] of 34) at 6 months and the improvement appeared to be sustained (10 [41.7%] of 24 vs 6 [20.0%] of 30) at 12 months. There was no change in the acne and hirsutism scores as well as serum T levels in both arms.

Conclusion(s): We found a possible benefit in menstrual cyclicity but a lack of improvement in hyperandrogenism in our Chinese population.

Clinical trial registration number: ChiCTR-TRC-09000670 (Chinese Clinical Trial Registry).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amenorrhea / blood
  • Amenorrhea / drug therapy*
  • Amenorrhea / ethnology
  • Amenorrhea / physiopathology
  • Asian People
  • Chi-Square Distribution
  • Double-Blind Method
  • Female
  • Hong Kong / epidemiology
  • Humans
  • Hyperandrogenism / blood
  • Hyperandrogenism / drug therapy*
  • Hyperandrogenism / ethnology
  • Hyperandrogenism / physiopathology
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Menstrual Cycle / drug effects
  • Placebo Effect
  • Polycystic Ovary Syndrome / blood
  • Polycystic Ovary Syndrome / drug therapy*
  • Polycystic Ovary Syndrome / ethnology
  • Polycystic Ovary Syndrome / physiopathology
  • Rosiglitazone
  • Testosterone / blood
  • Thiazolidinediones / adverse effects
  • Thiazolidinediones / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Hypoglycemic Agents
  • Thiazolidinediones
  • Rosiglitazone
  • Testosterone