Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

Description

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.

Conditions

Polycystic Ovary Syndrome, Hyperandrogenism, Normal Puberty

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Study Overview

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Study Details

Study overview

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.

Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)

Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

Condition
Polycystic Ovary Syndrome
Intervention / Treatment

-

Contacts and Locations

Charlottesville

Center for Research in Reproduction, University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III)
  • * Premenarcheal
  • * 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.

Ages Eligible for Study

7 Years to 14 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Virginia,

Christopher R McCartney, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

2024-12