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NCT00001259 · ClinicalTrials.gov registry record · Phase 1
A Treatment Study for Premenstrual Syndrome (PMS)
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00001259: Completed Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT00001259 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001259, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current 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 women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). 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 Estradiol Patches
- DRUG Progesterone
- DRUG Leuprolide
- DRUG Placebo injection
- DRUG Placebo patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 1992-08-11 |
| Est. Completion | 2020-02-06 |
| Phase | Phase 1 |
What the finished NCT00001259 record still lists
NCT00001259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Estradiol Patches is the first listed.
NCT00001259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001259 about?
NCT00001259 is a clinical study titled "A Treatment Study for Premenstrual Syndrome (PMS)". This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current...
What is the current status of trial NCT00001259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 1992-08-11. Estimated completion is 2020-02-06.
What interventions are being tested in trial NCT00001259?
The interventions under investigation include: Estradiol Patches (DRUG), Progesterone (DRUG), Leuprolide (DRUG), Placebo injection (DRUG), Placebo patch (DRUG).
Who is sponsoring clinical trial NCT00001259?
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 NCT00001259's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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