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Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)

8 Years
14 Years
Open (Enrolling)
Hyperandrogenemia, Polycystic Ovary Syndrome

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Trial Information

Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)

In this study, the investigators will aim to discover the effect of 7 days of estrogen and
progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the
investigators understand these normal processes, the investigators may be able to better
understand abnormalities of puberty.

Inclusion Criteria:

- Girls ages 8 to 14

- Tanner 1-3 pubertal stage

- Pre-menarchal

- Normal screening labs

Exclusion Criteria:

- Abnormal screening labs

- congenital adrenal hyperplasia.

- Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)

- Hemoglobin <12 mg/dL or hematocrit < 36% (Subjects will be offered the opportunity to
take iron supplementation for 60 days if their hematocrit is slightly low (33-36%)
(suggestive of iron deficiency anemia) and will then return for retesting of their

- Weight < 31 kg

- History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer,
or cervical cancer

- On hormonal medications (including oral contraceptive pills) or on medications known
to affect the reproductive axis within 3 months of the study

- Pregnant or breast feeding

- Participation in a research study within the past 30 days that involved taking a
study drug.

- Participation in a research study that involved taking up to or greater than 473 ml's
of blood within the past 60 days.

- Cigarette smoking

- History of surgery that required bedrest within the past 30 days

- Family history of hypercoagulability or unexplained thromboembolic disease (not in
setting of bedrest, surgery, or malignancy)

- In order to ensure an adequate number of younger girls, no more than 4 enrolled
subjects will be Tanner stage 3

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

LH Pulse frequency as a function of day 7 progesterone

Outcome Time Frame:

7 days following oral estrace and progesterone administration

Safety Issue:


Principal Investigator

John C. Marshall, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

April 2015

Related Keywords:

  • Hyperandrogenemia
  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome



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