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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Chris McCartney, University of Virginia
ClinicalTrials.gov Identifier:
NCT01773772
First received: May 17, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention
Female Puberty
Drug: Progesterone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • LH pulse frequency (number of LH pulses per hour) [ Time Frame: 19 hours [from 1400 hr to 0900 hr] ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2003
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

LH exhibits diurnal changes during early puberty, with nocturnal increases in LH pulse frequency and amplitude, but subsequent reduction during the following day. Progesterone (P) levels increase overnight in peripubertal girls, and P is the primary effector of LH pulse frequency slowing in adult women. The investigators hypothesize that nocturnal LH increases stimulate ovarian P, which in turn suppresses LH pulsatility during the following day. The investigators will assess this further using a protocol in which two doses of P or placebo are given to early pubertal girls, with subsequent assessment of LH pulses over 14 hours. The investigators hypothesize that in early pubertal girls, LH pulse frequency will be lower in girls receiving P compared to girls receiving placebo.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773772

Contacts
Contact: Anne C Gabel, BSc 434-243-6911 pcos@virginia.edu
Contact: Christopher R. McCartney, MD 434-243-6911 pcos@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Research in Reproduction Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Anne Gabel, BSc    434-243-6911    pcos@virginia.edu   
Principal Investigator: Christopher R. McCartney, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Christopher R. McCartney, MD University of Virginia
  More Information

No publications provided

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, U54HD028934-18
Study First Received: May 17, 2012
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014