Hormones Study for girls 8-14 years old
Assessment of the sensitivity of the hypothalamic GnRH pulse generator to estradiol and progesterone inhibition in early pubertal girls(JCM026)
Marshall John, C
Overview: Gonadotropin-releasing hormone (GnRH) is a hormone released from the brain that leads to the production of two hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), by the pituitary gland. LH and FSH control the production of female hormones (such as estrogen and progesterone) and the development of eggs by the ovary. Progesterone also causes a decrease in the number of GnRH pulses produced by the brain (and therefore the number of LH pulses from the pituitary). The ability of progesterone to decrease GnRH pulses seems to be very important for normal menstrual function in adult women. The purpose of this study is to learn more about how GnRH and LH pulses are controlled during puberty. We will observe the effect of 7 days of estrogen and progesterone on GnRH pulses in girls in early and midpuberty. We are recruiting girls ages 8-14 who have not yet started their period for this study. Study Visits: This study will require ~ 5-6 visits (3-4 outpatient and 2 overnight admissions) to the UVA Clinical Research Unit (CRU). • 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 is to draw blood (to make sure you are not anemic), which will take about 15 min. • The 3rd visit will be the first overnight admission. This visit to the CRU will last about 14 hours (~5pm – 7am). • The 4th and 5th visits are to draw blood (to check your estrogen and progesterone levels after 3 and 5 days of taking study medication, and to make sure you are not anemic). These will each take about 15 min. • The final visit will be the second overnight admission (to occur one week following the first overnight admission). This visit will be identical to the first overnight admission. Study medications: You will be given 2 medications if you participate in the study. Estrogen and progesterone are natural hormones. The amount of these hormones given in this study is similar to the amounts that are produced by girls’ bodies as they develop. • You will take estrogen pills by mouth once a day for seven days in between the two overnight admissions. • You will take progesterone by mouth three times a day at 7am, 3pm, and 11pm for seven days in between the two overnight admissions. Principal Investigator: John Marshall, MD
Compensation: The compensation for these studies is $200 at the completion of both overnight admissions. Compensation for travel may also be available.