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

Polycystic Ovary Syndrome Clinical Trial

— JCM026  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01428245
• Other study ID #: 14100
• Secondary ID: U54HD028934P50HD
• Status: Terminated
• Phase: N/A
• Start date: April 22, 2011
• Est. completion date: May 14, 2013

Study information

• Verified date: December 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 14, 2013
• Est. primary completion date: May 14, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Girls ages 8 to 14
• Tanner 1-3 pubertal stage
• Pre-menarchal
• Normal screening labs

Exclusion Criteria:

• Abnormal screening labs
• Congenital adrenal hyperplasia
• Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
• Hemoglobin <12 mg/dL or hematocrit < 36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit.)
• Weight < 31 kg
• History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
• On hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study
• Pregnant or breast feeding
• Participation in a research study within the past 30 days that involved taking a study drug.
• Participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days.
• Cigarette smoking
• History of surgery that required bedrest within the past 30 days
• Family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy)
• In order to ensure an adequate number of younger girls, no more than 4 enrolled subjects will be Tanner stage 3

Related Conditions & MeSH terms

• Hyperandrogenemia
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Center for Research in Reproduction, University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LH Pulse Frequency as a Function of Day 7 Progesterone	number of LH pulses per 11 hours on Day 7 of progesterone	7 days following oral estrace and progesterone administration