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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01428245
First received: August 31, 2011
Last updated: December 9, 2013
Last verified: December 2013

August 31, 2011
December 9, 2013
January 2009
April 2015   (final data collection date for primary outcome measure)
LH Pulse frequency as a function of day 7 progesterone [ Time Frame: 7 days following oral estrace and progesterone administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01428245 on ClinicalTrials.gov Archive Site
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Not Provided
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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)

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hyperandrogenemia
  • Polycystic Ovary Syndrome
  • 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
    Other Name: estradiol
Experimental: Progesterone, estrace

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days

oral estrace, 0.5-1 mg once a day for seven days

Interventions:
  • Drug: Progesterone
  • Drug: Estrace (estrogen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Female
8 Years to 14 Years
Yes
Contact: Anne C Gabel, BSc 434-243-6911 pcos@virginia.edu
Contact: John C Marshall, MD, PhD 434-243-6911 pcos@virginia.edu
United States
 
NCT01428245
14100, U54HD028934-18
No
John Marshall, University of Virginia
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: John C. Marshall, MD, PhD University of Virginia
University of Virginia
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP