At a glance
ClinicalIndex Comparison Record- ✓African-American women aged 18-35 years or Caucasian women aged 18-36 years
- ✓BMI <30
- ✓In good general health with normal TSH, prolactin, and hemoglobin
- ✓Normal BUN and Creatinine (<2 times upper limit of normal)
- ✕Postmenopausal status
- ✕Smoking >9 cigarettes per day
- ✕Evidence of androgen excess
- ✕Sensitivity to any medications used in the protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Race on Gonadotropin Responses to Short Term Negative and Positive Feedback Effects of Gonadal Steroids
In Brief
A Phase 2 clinical trial evaluating Estradiol steroid infusion and Progesterone steroid infusion for Premenopause and Healthy. Completed, enrolled 23 participants across 1 site.
Detailed Summary
The purpose of this study is to attempt to determine why estrogen levels are increased in African-American women as compared to Caucasian women by evaluating estrogen feedback on the brain. African-American women have increased bone mineral density, higher rates of twins, greater incidence of fibroids, and increased incidence of breast cancer below 40 years of age as compared to Caucasian women. These traits or illnesses are all believed to be estrogen-dependent. In fact, previous research has demonstrated increased estrogen levels in African-American women as compared to Caucasian women. However, the reason for these differences in estrogen levels has not been studied in humans. One possibility is that estrogen feedback on the brain differs between African-American and Caucasian women. Two small glands in the brain (hypothalamus and pituitary) respond to estrogen. The hypothalamus secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to secrete the reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating Hormone). These hormones act on the ovaries and signal the ovaries to produce estrogen and progesterone. Estrogen in the bloodstream then acts on the brain to stop this system when the blood has enough estrogen levels. This is called estrogen feedback. This study will determine whether there are differences in estrogen feedback between African-American and Caucasian women.
Study Details
Timeline
Interventions
Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr