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

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ClinicalTrials.gov Identifier: NCT01428245
Recruitment Status : Terminated (The research questions was changed/de-prioritized. Only one subject completed.)
First Posted : September 2, 2011
Results First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
John Marshall, University of Virginia

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperandrogenemia Polycystic Ovary Syndrome Drug: Progesterone Drug: Estrace (estrogen) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)
Actual Study Start Date : April 22, 2011
Actual Primary Completion Date : May 14, 2013
Actual Study Completion Date : May 14, 2013


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. LH Pulse Frequency as a Function of Day 7 Progesterone [ Time Frame: 7 days following oral estrace and progesterone administration ]
    number of LH pulses per 11 hours on Day 7 of progesterone



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428245


Locations
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United States, Virginia
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: John C. Marshall, MD, PhD University of Virginia
  Study Documents (Full-Text)

Documents provided by John Marshall, University of Virginia:
Informed Consent Form  [PDF] July 1, 2011

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Responsible Party: John Marshall, Director, Center for Research in Reproduction, University of Virginia
ClinicalTrials.gov Identifier: NCT01428245    
Other Study ID Numbers: 14100
U54HD028934 ( U.S. NIH Grant/Contract )
P50HD028934 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2011    Key Record Dates
Results First Posted: December 30, 2020
Last Update Posted: December 30, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Estradiol
Estrogens
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins