A randomized crossover study of medroxyprogesterone acetate and Diane-35 in adolescent girls with polycystic ovarian syndrome.

Objective: To investigate the effects of 4-month treatment of medroxyprogesterone acetate (MPA) and Diane-35 on the clinical and biochemical features of hyperandrogenism and quality of life of adolescent girls with polycystic ovarian syndrome (PCOS).

Design: A prospective, randomized, cross-over study.

Setting: An accredited pediatric and adolescent gynecology clinic of a university-affiliated tertiary hospital.

Participants: 76 adolescents girls aged 14 to 19 years old with PCOS were recruited from July 2007 to July 2010.

Interventions: Girls were randomized into 2 groups. Group 1 received oral MPA for 4 months, followed by a washout period of 4 months, and then Diane-35 for another 4 months. Group 2 received the same combination but in the reverse order.

Main Outcome Measures: Clinical and biochemical features of hyperandrogenism and quality of life were assessed.

Results: There was no significant difference between the 2 groups at baseline. No significant difference was found in the clinical and biochemical parameters of hyperandrogenism before and after treatment with MPA. Significant reduction of the acne score, LH/FSH ratio, and testosterone level was seen after taking Diane-35. Hirsutism was also improved but it did not reach statistical significant. When comparing post-MPA and post-Diane-35, the post-Diane-35 group had significantly improved acne score and LH/FSH ratio. No significant difference was found on quality of life between both groups after treatment.

Conclusion: Diane-35 may be a more suitable treatment option in adolescent girls diagnosed with PCOS when compared to MPA.