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Hormonal Therapy for Suicide Risk (CLEAR-3 Trial)
CLEAR-3 Trial Summary
This trial will study how hormonal changes affect suicide risk in women, in order to develop better treatments to eliminate the monthly worsening of suicide risk that many women experience.
CLEAR-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCLEAR-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CLEAR-3 Trial Design
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Who is running the clinical trial?
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- I was assigned female at birth and have not had my ovaries removed.I haven't used any hormonal treatments or devices for over a month.I do not have any chronic diseases or a family history of blood clots.I see a mental health provider at least every 3 months.My menstrual cycles are regularly between 25-35 days.I have had thoughts about suicide in the last month.I have not gone through menopause.
- Group 1: Active condition, then Inactive condition
- Group 2: Inactive condition, then active condition
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the trial open to geriatric patients?
"The target demographic for this research is individuals aged 18 years and over, with a maximum age of 45."
Has the FDA given authorization to Oral Micronized Progesterone 200mg?
"The safety of Oral Micronized Progesterone 200mg is assessed at 3, as this Phase 4 trial has already been approved."
What medical conditions respond positively to Oral Micronized Progesterone 200mg?
"Oral micronized progesterone 200mg is a commonly prescribed medication for absent menstrual cycles. It also has efficacy in treating hypoestrogenism, vasomotor symptoms associated with menopause, and breast-related issues."
Can I join the research project?
"This clinical trial seeks ninety volunteers between 18 and 45 years of age with recent suicidal ideations. Additional prerequisites include: receiving outpatient mental health treatment at least every 3 months, being postpartum for 1 year or more, in a premenopausal state, and having experienced some degree of suicidal thoughts within the past month."
How many individuals are actively involved in this investigation?
"Affirmative, the information contained on clinicaltrials.gov indicates that recruitment is in progress for this medical trial. Initially posted on September 15th 2020 and last updated August 17th 2022, the research is searching to enroll 90 volunteers at 1 site."
Does this investigation currently admit participants?
"Confirmation on clinicaltrials.gov suggests that recruitment for this trial is ongoing; the study was initially made public on September 15th 2020 and most recently updated on August 17th 2022."
Are there any additional investigations into the efficacy of Oral Micronized Progesterone 200mg?
"Currently, there are 82 ongoing examinations of Oral Micronized Progesterone 200mg with 16 trials in their ultimate stage. These experiments predominantly take place at Cheras and Kuala Lumpur but can be found across a total of 986 healthcare centres worldwide."
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