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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

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 2, 2011
Results First Submitted Date  ICMJE November 10, 2020
Results First Posted Date  ICMJE December 30, 2020
Last Update Posted Date December 30, 2020
Actual Study Start Date  ICMJE April 22, 2011
Actual Primary Completion Date May 14, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
LH Pulse Frequency as a Function of Day 7 Progesterone [ Time Frame: 7 days following oral estrace and progesterone administration ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Official Title  ICMJE Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hyperandrogenemia
  • Polycystic Ovary Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 5, 2020)
3
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2011)
10
Actual Study Completion Date  ICMJE May 14, 2013
Actual Primary Completion Date May 14, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 8 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01428245
Other Study ID Numbers  ICMJE 14100
U54HD028934 ( U.S. NIH Grant/Contract )
P50HD028934 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Marshall, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: John C. Marshall, MD, PhD University of Virginia
PRS Account University of Virginia
Verification Date December 2020

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