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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 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001259
The ClinicalTrials.gov registry entry for NCT00001259 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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 Estradiol Patches is the first listed.
NCT00001259 reports 0 study locations.
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.
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