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NCT00455962 · ClinicalTrials.gov registry record · Phase 1
Effect of Race on Gonadotropin Responses
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00455962: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT00455962 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00455962, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
Estradiol levels are consistently higher in African-American vs Caucasian women across the menstrual cycle. This study was designed to determine if African-American women are more sensitive to estrogen positive feedback to generate the preovulatory LH surge using a controlled estrogen infusion paradigm.
Interventions
- DRUG Estradiol steroid infusion
- DRUG Progesterone steroid infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT00455962 record still lists
NCT00455962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Estradiol steroid infusion is the first listed.
NCT00455962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00455962 about?
NCT00455962 is a clinical study titled "Effect of Race on Gonadotropin Responses". 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 fibroi...
What is the current status of trial NCT00455962?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2005-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00455962?
The interventions under investigation include: Estradiol steroid infusion (DRUG), Progesterone steroid infusion (DRUG).
Who is sponsoring clinical trial NCT00455962?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00455962's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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