drugset / Trial / NCT01427595

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

NCT01427595

NaSingle-groupOpen-labelBasic science

Summary

Many, but not all, girls with high levels of the male hormone testosterone go on to develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of difficulty becoming pregnant. The investigators do not understand why some girls with high hormones develop PCOS and others do not. In a previous study by our group, some girls with high levels of male hormones had abnormalities in the secretion of another hormone, called luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had normal LH secretion. The girls with the abnormal LH secretion had higher levels of another hormone, called insulin, than the girls with normal LH secretion. The investigators will test whether metformin, an insulin-sensitizing agent, changes the effects of high male hormone levels in adolescent girls, specifically by looking at their LH secretion response following metformin treatment.

Timeline

Start
2009-02-18
Primary completion
2015-01-17
Completion
2015-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg Oral
Subject Metformin Small molecule 2000 mg Oral
Background Estradiol Other / unclassified 0.5 mg Oral
Background Estradiol Other / unclassified 1 mg Oral
Background Progesterone Other / unclassified 25 mg Oral
Background Progesterone Other / unclassified 100 mg Oral