Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
NCT ID: NCT01428245
Last Updated: 2020-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2011-04-22
2013-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Progesterone, estrace
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days
oral estrace, 0.5-1 mg once a day for seven days
Progesterone
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
Estrace (estrogen)
oral estrace, 0.5-1 mg once a day for seven days
Interventions
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Progesterone
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
Estrace (estrogen)
oral estrace, 0.5-1 mg once a day for seven days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tanner 1-3 pubertal stage
* Pre-menarchal
* Normal screening labs
Exclusion Criteria
* Congenital adrenal hyperplasia
* Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
* 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 breast feeding
* 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)
* In order to ensure an adequate number of younger girls, no more than 4 enrolled subjects will be Tanner stage 3
8 Years
14 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Virginia
OTHER
Responsible Party
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John Marshall
Director, Center for Research in Reproduction
Principal Investigators
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John C. Marshall, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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