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Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Normal and Hyperandrogenemic Adolescent Girls (JCM010)


N/A
8 Years
18 Years
Open (Enrolling)
Female
Hyperandrogenemia, Polycystic Ovary Syndrome (PCOS)

Thank you

Trial Information

Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Normal and Hyperandrogenemic Adolescent Girls (JCM010)


Inclusion Criteria:



- Girls ages 8 to 18

- Hyperandrogenemic (testosterone level > 0.4 ng/mL and/or hirsutism)

- Normal screening labs (with exception of the expected hormonal abnormalities inherent
in hyperandrogenemia)

Exclusion Criteria:

- Abnormal screening labs (with exception of the expected hormonal abnormalities
inherent in hyperandrogenemia)

- Congenital adrenal hyperplasia.

- 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
hemoglobin/hematocrit.)

- 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 breastfeeding

- 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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Reduction in leutenizing hormone pulse frequency after one week of estradiol and progesterone

Outcome Time Frame:

7 days following estradiol and progesterone treatment

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:

8588

NCT ID:

NCT01425541

Start Date:

April 2000

Completion Date:

April 2015

Related Keywords:

  • Hyperandrogenemia
  • Polycystic Ovary Syndrome (PCOS)
  • Polycystic Ovary Syndrome

Name

Location

Center for Research in ReproductionCharlottesville, Virginia  22908