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Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia

This study is currently recruiting participants.
Verified June 2012 by University of Virginia
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01428089
First received: August 30, 2011
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

During childhood, the levels of the hormones GnRH (Gonadotropin-releasing hormone), LH (luteinizing hormone), FSH (follicle stimulating hormone), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of being increased all the time).The purpose of this study is to see how quickly progesterone reduces LH pulses. The study is also meant to find out whether too much testosterone (also a hormone) in the blood causes problems with the ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent the nighttime increase of 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 the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.


Condition Intervention
Polycystic Ovary Syndrome
Hyperandrogenism
 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: Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Average Leuteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hourly hormone measurements during sampling period. [ Time Frame: 1100hr to 0700 hr ] [ Designated as safety issue: No ]
    The hourly measurements of Progesterone, FSH, Estrogen, and Testosterone will be analyzed in a similar manner as the LH interpulse interval data.


Estimated Enrollment: 40
Study Start Date: May 2008
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 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)
 Drug: Progesterone
Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml) or placebo at 1100, 1500, and 1900 h.
Placebo Comparator: placebo
placebo at 1100, 1500, and 1900 h.
 Drug: Placebo
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 midpuberty (i.e., late Tanner I [estradiol level > 20 pg/mL], Tanner II, or Tanner III)
  • Premenarcheal

Exclusion Criteria:

  • Pregnancy
  • Inability to comprehend what will be done during the study or why it will be done
  • 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 TSH values)
  • Total testosterone > 200 ng/dl
  • Basal (follicular) 17-OHP > 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
  • DHEA-S > 800 mcg/dl
  • Elevation of prolactin > 2 times upper limit of normal
  • Weight less than 26 kg.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428089

Contacts
Contact: Michelle Y. Abshire, PhD 434-243-6911 pcos@virginia.edu
Contact: John C. Marshall, MD, PhD 434-243-6911 pcos@virginia.edu

Locations
United States, Virginia
Center for Research in Reproduction, University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Michelle Y. Abshire, PhD     434-243-6911     pcos@virginia.edu    
Principal Investigator: John C. Marshall, MD, PhD            
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: John C. Marshall, MD, PhD University of Virginia
  More Information

No publications provided

Responsible Party: John Marshall, Director, Center for Research in Reproduction, University of Virginia
ClinicalTrials.gov Identifier: NCT01428089     History of Changes
Other Study ID Numbers: 13660, U54HD028934-18
Study First Received: August 30, 2011
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
hyperandrogenemia

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Hyperandrogenism
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
 Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013