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


N/A
9 Years
14 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Hyperandrogenism

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Outcome Measure:

Average Leuteinizing hormone (LH) interpulse interval and the total number of LH pulses

Outcome Time Frame:

1100hr to 0700 hr

Safety Issue:

No

Principal Investigator

John C. Marshall, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

13660

NCT ID:

NCT01428089

Start Date:

May 2008

Completion Date:

April 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • Hyperandrogenism
  • hyperandrogenemia
  • Polycystic Ovary Syndrome
  • Hyperandrogenism

Name

Location

Center for Research in Reproduction, University of VirginiaCharlottesville, Virginia  22908