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

NCT01425541 | Unknown

• 3 other identifiers: 8588JCM010U54HD028934-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

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

  7 days following estradiol and progesterone treatment

Study Arms (1)

estrogen, progesterone

EXPERIMENTAL

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; Drug: Progesterone

Interventions

estrace DRUG

0.5-1 mg once a day PO for 7 days

Also known as: Estrogen

estrogen, progesterone

Progesterone DRUG

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

estrogen, progesterone

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center for Research in Reproduction

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Estradiol; Estrogens; Progesterone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Officials

• Chris McCartney, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Research in Reproduction

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: April 1, 2000
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-11

Locations

US (1)