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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01425541
First received: August 26, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Hyperandrogenemia
Polycystic Ovary Syndrome (PCOS)
Drug: estrace
Drug: Progesterone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Normal and Hyperandrogenemic Adolescent Girls (JCM010)

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Reduction in luteinizing hormone pulse frequency after one week of estradiol and progesterone [ Time Frame: 7 days following estradiol and progesterone treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2000
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: estrogen, progesterone
Estrace, 0.5-1 mg once a day Micronized progesterone powder (Spectrum Chemical Manufacturing Corporation, Irving, CA), Three times a day at 0700, 1500, and 2300 hr
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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425541

Contacts
Contact: Anne C Gabel, BSc 434-243-6911 pcos@virginia.edu
Contact: John C. Marshall, MD, PhD 434-243-6911 pcos@virginia.edu

Locations
United States, Virginia
Center for Research in Reproduction Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Anne C Gabel, Bsc    434-243-6911    pcos@virginia.edu   
Principal Investigator: John C. Marshall, MD, PhD         
Sub-Investigator: Christopher R McCartney, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: John C. Marshall, MD, PhD University of Virginia
  More Information

No publications provided

Responsible Party: John Marshall, Director, Center for Research in Reproduction, University of Virginia
ClinicalTrials.gov Identifier: NCT01425541     History of Changes
Other Study ID Numbers: 8588, JCM010, U54HD028934-18
Study First Received: August 26, 2011
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Cysts
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on October 23, 2014