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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

Thank you

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 Virginia Charlottesville, Virginia  22908