Adolescent Hormone Study
Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM025)
Overview: Girls with high levels of the male hormone testosterone are at risk for developing polycystic ovary syndrome (PCOS) as adults. Women with PCOS have irregular menstrual periods, facial and male-patterned body hair, a more difficult time becoming pregnant, and are at risk for obesity and diabetes. The purpose of this study is to understand excess insulin worsens the effects of high male hormone levels in adolescent girls. In this study we will use a drug called metformin (Glucophage) to lower insulin levels. We need girls for this study ages 10-17 who have symptoms (e.g. male-patterned body hair or acne) or lab evidence of elevated male hormone levels (which can happen in girls who are overweight or have irregular periods). Study Procedures: This study will require ~6 outpatient visits and 4 overnight admissions to the UVA Clinical Research Unit (CRU) over ~4 months. • The 1st visit will last about 1 1/2 hr. We will consent you for the study and draw blood to make sure it is safe for you to participate in the study. • The 2nd visit will be the first overnight admission. This visit to the CRU will last about 16 hr (5pm–9am). If you are having periods, this will be timed to your menstrual cycle. Otherwise, this visit can occur any time following screening. (You may be asked to come in for another outpatient blood draw ~1-5 days prior to this visit to make sure you are not anemic). • You will take estrogen and progesterone study medications the week after this visit. • The 3rd and 4th visits are to draw blood to check your hormone levels 3 and 5 days after taking study medication, and to make sure you are not anemic. These will each take about 15 min. • The 5th visit will be the second overnight admission (to occur one week after the first overnight admission). This visit will be identical to the first overnight admission, lasting ~ 14 hr (5pm-7am). • You will then start taking metformin and will increase the dose slowly over the next month. • The 6th visit is to draw blood to check your hormone levels after ~ 30-40 days of taking metformin. • The 7th visit will be the 3rd overnight admission. This overnight admission will be identical to the 1st overnight admission and will last ~16 hours (5pm–9am). (You may be asked to come in for another outpatient blood draw ~1-5 days prior to this visit to make sure you are not anemic) • You will again take estrogen and progesterone study medications the week after this visit. • The 8th and 9th visits are to draw blood to check your estrogen and progesterone levels (after 3 and 5 days of medication), and to make sure you are not anemic. These will each take about 15 min. • The 10th visit will be the 4th overnight admission (to occur one week following the 3rd overnight admission). This overnight admission will be identical to the 2nd overnight admission, lasting ~14 hr (5pm-7am). Study medications: You will be given 3 medications if you participate in the study. Estradiol and progesterone are natural hormones, given in amounts similar to those produced by girls normally.. • You will take estradiol pills by mouth once a day for seven days in between the 1st and 3rd overnight admissions and in between the 3rd and 4th overnight admissions. • You will take progesterone syrup by mouth three times a day at 7am, 3pm, and 11pm for seven days in between the 1st and 3rd overnight admissions and in between the 3rd and 4th overnight admissions. • You will begin taking metformin pills by mouth daily following the 2nd overnight admission. You will start with 1 pill, once a day, and increase the dose every 7 days until you are taking 2 pills in the morning and 2 pills at night. You will take this dose for the remainder of the study. Compensation: You will receive $400 at the completion of all four overnight admissions. Reimbursement for travel is also available.
Polycystic Ovarian Syndrome
$400 at the completion of all four overnight admissions.
Cinthya Yesenia Obando Perez