Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

This study is currently recruiting participants.
Verified December 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01428089
First received: August 30, 2011
Last updated: December 9, 2013
Last verified: December 2013

August 30, 2011
December 9, 2013
May 2008
April 2015   (final data collection date for primary outcome measure)
Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ] [ Designated as safety issue: No ]
Average Leuteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01428089 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)

During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Polycystic Ovary Syndrome
  • Hyperandrogenism
  • 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.
  • Drug: Placebo
    Placebo
  • Experimental: Progesterone
    Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)
    Intervention: Drug: Progesterone
  • Placebo Comparator: placebo
    placebo at 1100, 1500, and 1900 h.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female volunteers in early to mid-puberty (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 thyroid-stimulating hormone (TSH) values
  • Total testosterone > 200 ng/dl
  • Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
  • Dehydroepiandrosterone sulfate (DHEA-S) > 800 mcg/dl
  • Elevation of prolactin > 2 times upper limit of normal
  • Weight less than 26 kg.
Female
9 Years to 14 Years
Yes
Contact: Anne C Gabel, BSc 434-243-6911 pcos@virginia.edu
Contact: John C Marshall, MD, PhD 434-243-6911 pcos@virginia.edu
United States
 
NCT01428089
13660, U54HD028934-18
No
John Marshall, University of Virginia
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: John C. Marshall, MD, PhD University of Virginia
University of Virginia
December 2013

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