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Assessment of the Sensitivity of the Hypothalamic Gonadotropin-releasing Hormone (GnRH) Pulse Generator to Estradiol and Progesterone Inhibition

Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperandrogenemia; Polycystic Ovary Syndrome (PCOS)

Intervention: estrace (Drug); Progesterone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
John C. Marshall, MD, PhD, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Anne C Gabel, BSc, Phone: 434-243-6911, Email: pcos@virginia.edu

Summary

Girls with high levels of the male hormone testosterone often develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. Women with PCOS also have difficulty becoming pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as they grow up. Most girls continue to have high levels of male hormone as adults. In addition, girls with elevated levels of male hormones often have lower fertility rates in adulthood. In this study the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls and women with the goal of understanding how and why some girls and women have higher levels of male hormone and the causes of PCOS. If investigators understand the causes of these disorders, they may be able to better treat them and perhaps even learn how to prevent the development of PCOS.

Clinical Details

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

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

Primary outcome: Reduction in luteinizing hormone pulse frequency after one week of estradiol and progesterone

Eligibility

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Female.

Criteria:

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)

Locations and Contacts

Anne C Gabel, BSc, Phone: 434-243-6911, Email: pcos@virginia.edu

Center for Research in Reproduction, Charlottesville, Virginia 22908, United States; Recruiting
Anne C Gabel, Bsc, Phone: 434-243-6911, Email: pcos@virginia.edu
John C. Marshall, MD, PhD, Principal Investigator
Christopher R McCartney, MD, Sub-Investigator
Additional Information

Starting date: April 2000
Last updated: December 9, 2013

Page last updated: August 23, 2015

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