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Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

NCT01425541 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-02

No results posted yet for this study

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.

Conditions

  • Hyperandrogenemia
  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

estrace

0.5-1 mg once a day PO for 7 days

DRUG

Progesterone

20 mg/ml, 25-100 mg, Three times a day at 0700, 1500, and 2300 hr for 7 days

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Chris McCartney, MD · University of Virginia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425541 on ClinicalTrials.gov