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NCT03689543 · ClinicalTrials.gov registry record · Phase 2
Estrogen Receptor Beta and Mood
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT03689543 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 74 participants.
The verdict
NCT03689543, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
Background: Our previous studies have found that women who had depression during the perimenopause may have mood symptoms again if they stop estrogen therapy. Estrogen acts in the brain and other tissues by binding to estrogen receptors. There are two main types of estrogen receptors. They are estrogen receptor alpha and beta. Several studies have shown that estrogen receptor beta may play an important role in anxiety- and depressive-like behaviors in animals. Objectives: To examine a possible mechanism mediating the effects of estradiol-withdrawal on mood symptoms in asymptomatic postmenopausal women with a past perimenopausal depression. To evaluate the efficacy and safety of a selective estrogen receptor (ER) beta agonist (Lilly Compound LY500307) to prevent estradiol withdrawal-induced mood symptoms. Eligibility: Healthy, non-depressed postmenopausal women, ages 45 to 65, with a well-documented past perimenopause-related depression (within 12 years) and whose mood systems got better with estradiol Design: Participants will be screened with: Medical history Physical exam Blood tests Psychiatric interview Gynecological exam * Participants able to get pregnant must use effective barrier birth control throughout the study. * During the first 3 weeks, participants will wear an estrogen patch. It is 1x2 inches and will be replaced every 3 days. * For the next 3 weeks, participants will take 3 study capsules every morning. They will not know if they get the study drug or placebo. * Some participants will also take a progesterone-like drug for 1 week at the end of the medication phase of the study. * Participants will have 9 one-hour study visits. They will have blood samples and vital signs taken. They will answer questions about mood and behavior symptoms. * Participants will keep a daily log of these symptoms. * Participants will have 2 transvaginal ultrasounds. A probe is temporarily placed 2-3 inches into the vaginal canal and sound waves are used to c
Interventions
- OTHER Placebo
- DRUG Estradiol
- DRUG Provera
- DRUG ER Beta Agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-05-23 |
| Est. Completion | 2024-09-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03689543
The ClinicalTrials.gov registry entry for NCT03689543 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 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 4 interventions - of which Placebo is the first listed.
NCT03689543 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03689543 about?
NCT03689543 is a clinical study titled "Estrogen Receptor Beta and Mood". Background: Our previous studies have found that women who had depression during the perimenopause may have mood symptoms again if they stop estrogen therapy. Estrogen acts in the brain and other tissues by binding to estrogen receptors. There are two main types of estrogen receptors. They are estr...
What is the current status of trial NCT03689543?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2019-05-23. Estimated completion is 2024-09-09.
What interventions are being tested in trial NCT03689543?
The interventions under investigation include: Placebo (OTHER), Estradiol (DRUG), Provera (DRUG), ER Beta Agonist (DRUG).
Who is sponsoring clinical trial NCT03689543?
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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