Status:
TERMINATED
Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hyperandrogenemia
Polycystic Ovary Syndrome
Eligibility:
FEMALE
8-14 years
Phase:
NA
Brief Summary
Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH cont...
Detailed Description
In this study, the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the investigators understand th...
Eligibility Criteria
Inclusion
- Girls ages 8 to 14
- Tanner 1-3 pubertal stage
- Pre-menarchal
- Normal screening labs
Exclusion
- Abnormal screening labs
- 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
Key Trial Info
Start Date :
April 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01428245
Start Date
April 22 2011
End Date
May 14 2013
Last Update
December 30 2020
Active Locations (1)
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1
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908