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Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)

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ClinicalTrials.gov Identifier: NCT01773772
Recruitment Status : Active, not recruiting
First Posted : January 23, 2013
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Chris McCartney, University of Virginia

Brief Summary:
The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if these normal processes can be understood, the investigators may be able to better understand abnormalities of puberty.

Condition or disease Intervention/treatment Phase
Female Puberty Drug: Progesterone Drug: Placebo Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)
Study Start Date : June 2003
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty

Arm Intervention/treatment
Experimental: Progesterone
Subjects will take 25-50 mg oral micronized P or placebo at 1600 h and again at 2000 h. P dosing will be based on weight, with 25 mg administered to girls < 42kg and 50 mg given to those > or = 42 kg.
Drug: Progesterone
Subjects will take 25-50 mg oral micronized progesterone at 1600 h and again at 2000 h. Progesterone dosing will be based on weight, with 25 mg administered to girls < 42kg and 50 mg given to those or = to 42 kg.

Placebo Comparator: Placebo
Subjects will take placebo at 1600 h and again at 2000 h.
Drug: Placebo
Subjects will take oral placebo suspension at 1600 h and again at 2000 h.




Primary Outcome Measures :
  1. LH pulse frequency (number of LH pulses per hour) [ Time Frame: 19 hours [from 1400 hr to 0900 hr] ]


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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female volunteers in early to mid-puberty (i.e. late Tanner 1 [estradiol level >20 pg/ml], Tanner 2, or Tanner 3)
  • Premenarcheal

Exclusion Criteria:

  • BMI-for-age > 85th percentile or < 5th percentile
  • Pregnancy
  • Inability to comprehend what will be done during the study or why it will done
  • Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
  • History of allergy to progesterone (which is extremely rare)
  • Hemoglobin less than 12 g/dl and hematocrit less than 36%
  • Persistently abnormal sodium, potassium, or bicarbonate (i.e. confirmed on repeat)
  • Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
  • Total bilirubin > 1.5 times upper limit of normal (i.e. confirmed on repeat)
  • Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
  • Untreated hypo- or hyperthyroidism, reflected by persistently abnormal thyroid-stimulating hormone (TSH) values
  • Premature adrenarche (i.e., occurring before age 8 y)
  • Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (confirmed on repeat)
  • Dehydroepiandrosterone-sulfate (DHEA-S) > age-appropriate upper limit of normal (confirmed on repeat)
  • Hyperprolactinemia (confirmed on repeat)
  • Weight less than 25 kg

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): NCT01773772


Locations
United States, Virginia
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Christopher R. McCartney, MD University of Virginia

Responsible Party: Chris McCartney, Associate Professor, Department of Medicine, Endocrinology and Metabolism, University of Virginia
ClinicalTrials.gov Identifier: NCT01773772     History of Changes
Other Study ID Numbers: 10504
U54HD028934 ( U.S. NIH Grant/Contract )
P50HD028934 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We do not have current plans to share IPD

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs