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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: Completed Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT00001322 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures the severity of symptoms accompanying depression. Each item has a minimum score of 0 and a maximum score of 3, with higher numbers consistent with more severe symptoms. The score of each item is summed to amount the overall BDI score, with a minimum score of 0 and a maximum score of 63. Higher BDI scores are consistent with more severe depression. Score of 16 or greater is consistent with clinical depres
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 |
What the finished NCT00001322 record still lists
NCT00001322 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 5 interventions - of which Progesterone is the first listed.
NCT00001322 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001322's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 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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