Healthy Clinical Trial
Official title:
Effect of Race on Gonadotropin Responses to Short Term Negative and Positive Feedback Effects of Gonadal Steroids
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.
Several independent lines of evidence have suggested that reproductive endocrine dynamics
may differ between African-American (AAW) and Caucasian (CW) women. There is an increased
incidence of dizygotic twinning in African-American women and a further increase in the
incidence reported in African women compared to Caucasian, Hispanic and Asian populations.
While the etiology of dizygotic twinning is not well understood, an increase in its
incidence may imply an alteration in the integrated control of the reproductive axis which
usually favors development of a single ovulatory follicle. It is widely appreciated that the
incidence of leiomyomas is increased in African-American women. Growth factors are likely to
play a role in their control, but there is also ample evidence that leiomyomas are
responsive to gonadal steroids, decreasing in size following the menopause and in response
to hypoestrogenism caused by gonadotropin downregulation. African-American women under 40
years of age have a higher risk of breast cancer than women of all other ethnicities in that
age group, again raising the question of whether there are also differences in reproductive
hormone dynamics. Finally, bone density is increased in African-American women. In a
cross-sectional study of 54 African-American and 39 Caucasian women between the ages of 20
and 90, Perry et al found that the increase in bone density in AAW was associated with
increased serum levels of both estradiol and testosterone. Woods et al also described
increased levels of estradiol, estrone and androstenedione levels in AAW compared with
control women on a controlled low-fat, high-fiber diet. In contrast, a recent longitudinal
cohort study has suggested that AAW have lower levels of estradiol with increasing age and
BMI in comparison with CW. We have compared reproductive hormone levels in AAW and CW < 35
years old with a history of regular ovulatory cycles. Our preliminary data indicate that in
comparison to age and BMI matched CW, estradiol levels are consistently elevated across the
cycle in AAW in the absence of changes in LH, FSH, progesterone, inhibin A or inhibin B.
These relationships suggest both altered negative and forward feedback interrelationships
between FSH and LH and estradiol in the setting of normal inhibin levels. In the current
protocol we will seek to understand the mechanisms underlying these feedback differences,
which have never been addressed in these populations.
A graded infusion of estradiol and progesterone can be used to assess differences in
negative and positive feedback of gonadal steroids on LH and FSH. We have hypothesized that
differences exist in feedback regulation of the hypothalamus and pituitary as a function of
African-American or Caucasian race in reproductive aged women.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |