NCT01428245

Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 8 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH control the production of female hormones (such as estrogen and progesterone) and the development of eggs by the ovary. Progesterone and estrogen then decrease the number of GnRH pulses produced by the brain (and therefore the number of LH pulses from the pituitary). The ability 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. The information gathered in this study will hopefully allow us to learn more about how menstrual cycles are normally established in girls during puberty.

Detailed description

In this study, the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.

Conditions

• Hyperandrogenemia
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Progesterone	oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
DRUG	Estrace (estrogen)	oral estrace, 0.5-1 mg once a day for seven days

Timeline

• Start date: 2011-04-22
• Primary completion: 2013-05-14
• Completion: 2013-05-14
• First posted: 2011-09-02
• Last updated: 2020-12-30
• Results posted: 2020-12-30

Locations

1 site across 1 country: United States