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NCT00001322 · ClinicalTrials.gov registry record · Phase 1
The Effects of Reproductive Hormones on Mood and Behavior
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00001322 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 100 participants.
The verdict
NCT00001322, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
Interventions
- DRUG Progesterone
- DRUG Estradiol
- DRUG Placebo patch
- DRUG Leuprolide Acetate 3.75
- DRUG Placebo suppository
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1994-06-09 |
| Est. Completion | 2020-03-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001322
The ClinicalTrials.gov registry entry for NCT00001322 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Progesterone is the first listed.
NCT00001322 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001322 about?
NCT00001322 is a clinical study titled "The Effects of Reproductive Hormones on Mood and Behavior". This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle leve...
What is the current status of trial NCT00001322?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 1994-06-09. Estimated completion is 2020-03-03.
What interventions are being tested in trial NCT00001322?
The interventions under investigation include: Progesterone (DRUG), Estradiol (DRUG), Placebo patch (DRUG), Leuprolide Acetate 3.75 (DRUG), Placebo suppository (DRUG).
Who is sponsoring clinical trial NCT00001322?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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