Clinical Trial: Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)

Brief Summary: Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.

Detailed Summary:

Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is often delayed until adulthood. At least 50% of adult women with PCOS are obese, resulting in a more severe clinical picture. Obesity among adolescents has been increasing in recent years, with overrepresentation of females who show evidence of hyperandrogenism and irregular periods, suggesting an association of obesity and PCOS at an early age. Recent data, however, have drawn attention to the long-term risks of PCOS, including diabetes and cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk of diabetes and heart disease. Traditional treatments with oral contraceptives are associated with reduction in serum androgens and improvements in menstrual cycles in adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve metabolic features of PCOS, but combination therapy with oral contraceptives has never been studied in the obese adolescent with PCOS.

The major hypothesis of this proposal is that metformin will improve the metabolic profile of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a secondary hypothesis will be that compliance with a concurrent lifestyle modification program with be associated with the most significant improvements.


Sponsor: University of Rochester

Current Primary Outcome: Reduction in Abdominal Fat as Measured by Waist Circumference. [ Time Frame: baseline and 24 weeks ]

Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention


Original Primary Outcome: 24 week trial to compare effect of metformin to placebo, in combination with oral contraceptives with respect to change in metabolic parameters of increased cardiovascular risk and insulin resistance.

Current Secondary Outcome:

  • Change in Weight Post Minus Pre Intervention. [ Time Frame: baseline and 24 weeks ]
    Body mass index change in adolescents enrolled in lifestyle intervention program
  • Total Testosterone Change [ Time Frame: baseline and 24 weeks ]
    Change in total testosterone post minus pre intervention
  • Change in Sex Hormone Binding Globulin (SHBG) [ Time Frame: baseline and 24 weeks ]
    SHBG concentration post minus pre-intervention


Original Secondary Outcome: Assess the effectiveness & impact of a lifestyle management program in combination with oral contraceptives +/- metformin in producing weigh reduction and improvement in fitness capacity in obese adolescents with PCOS.

Information By: University of Rochester

Dates:
Date Received: January 27, 2006
Date Started: January 2006
Date Completion:
Last Updated: April 28, 2015
Last Verified: April 2011