Suicidal IdeationPhase 4CLEAR-3NCT04112368
Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach
A Phase 4 study testing Estradiol Transdermal Patch 0.1 mg/24 hrs, Oral Micronized Progesterone 200mg and Inactive Clear Patch in people with Suicidal Ideation, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cyclical changes in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Estradiol Transdermal Patch 0.1 mg/24 hrs, Oral Micronized Progesterone 200mg and Inactive Clear Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ability to adhere to medication regimen
- Speaks English
- Assigned female at birth with intact ovaries
- Premenopausal
- Normal menstrual cycles between 25-35 days
- Under current care of an outpatient mental health provider with visits occurring at least once every 3 months.
Show all 11Show fewer
- At least 1 year postpartum.
- Willing to use a barrier method of birth control during the study.
- Normal weight (BMI between 18-29)
- Must report at least some recent suicidal ideation (in the past month) at the time of recruitment.
- Must be categorized as having acceptably low imminent risk for suicidal crisis/attempt by a licensed clinical psychologist utilizing evidence-based clinical and research guidelines for imminent suicide risk management.
Who cannot join
- Must not be pregnant, breastfeeding, or trying to become pregnant.
- Must not be taking any form of exogenous hormones or hormonal intrauterine device, and must have ended previous use of hormonal preparations at least one month prior to the study.
- Must not have a personal history of any chronic medical condition, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease, and no personal or first degree family history of thromboembolic events.
- Any current cigarette smoking is exclusionary.
- Must not report a history of clinical diagnosis or treatment for postpartum depression or premenstrual dysphoric disorder (Note: Premenstrual Dysphoric - - - Disorder diagnosis must have been made based on prospective daily ratings).
- Must not report any history of manic episode, any history of psychotic symptoms, or current substance use disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Neuropsychiatric Institute
Chicago, Illinois, 60612
About this study
Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cyclical changes in hormones and their metabolites influence short-term risk of suicide. The data acquired will contribute to our understanding of the biology of acute suicide risk and advance efforts to develop safe and effective treatments that eliminate predictable monthly worsening of suicide risk in reproductive-age females.
Read the detailed description
Suicide is the second leading cause of death among women of reproductive age, and female suicide attempts occur most frequently around menses (perimenstrually), when estradiol (E2) and progesterone (P4) fall rapidly. A recent prospective study demonstrated that suicidal ideation (SI) and attempts peak perimenstrually in natural cycles, and that this perimenstrual worsening of SI can be prevented by administering stabilizing doses of E2+P4 (relative to placebo). Therefore, while E2+P4 withdrawal is a viable model of proximal suicide risk in females with SI, mechanisms are unclear. GABAergic neuroactive steroid metabolites of ovarian hormones (e.g., allopregnanolone), exert potent sedative and antidepressant effects; we hypothesize that acute perimenstrual withdrawal from these hormone metabolites may increase suicide risk by increasing hyperarousal and hopelessness. The long-term objectives of this research are to (1) use the menstrual cycle as a model to probe the proximal mechanisms of suicide, and (2) develop long-term treatments that eliminate hormonal contributions to suicide. The objective of the current work is to use a crossover placebo-controlled trial of E2+P4 stabilization (vs. natural E2+P4 withdrawal under placebo) in the perimenstrual weeks to probe behavioral (hopelessness, hyperarousal) and molecular/genetic (neuroactive steroid levels, mRNA expression for enzymes critical for synthesizing neuroactive steroids) mediators of perimenstrual suicide risk. Design: In this mechanistic trial, 90 female outpatients with past-month SI will complete two counterbalanced conditions: (1) two weeks of placebo during natural perimenstrual E2+P4 withdrawal, and (2) two weeks of perimenstrual E2+P4 stabilization (.1mg/day transdermal estradiol + 200mg/day oral micronized progesterone) to prevent withdrawal. Five labs per condition will capture changes in gas chromatography mass spectrometry (GC-MS) quantified neuroactive steroids, messenger ribonucleic acid (mRNA) expression for enzymes critical for synthesizing neuroactive steroids, and physiological arousal. Our app (BiAffect) will collect ecological momentary assessments (EMA; 4x/day) of behavioral constructs and SI, and will passively track arousal via movement and typing speed instability. Specific Aims. Aim 1 is to evaluate hyperarousal and hopelessness as interacting mechanisms by which perimenstrual E2+P4 withdrawal (vs. experimental E2+P4 stabilization) increases proximal suicide risk. Aim 2 is to evaluate neuroactive steroid withdrawal as a mechanism by which perimenstrual E2+P4 withdrawal (vs. stabilization) increases proximal suicide risk. If appropriate, a multilevel path model will test a path in which E2+P4 withdrawal (vs. stabilization) causes neuroactive steroid withdrawal, which increases in hopelessness and hyperarousal, which in turn increases proximal suicide risk. Relevance. By conducting a mechanistic experiment to probe the mediators of a known cause of proximal suicide risk, the proposed research responds to public calls from the National Institute of Mental Health (NIMH)-sponsored Suicide Research Prioritization Agenda to identify modifiable causes of proximal suicide risk.
- Conditions
- Suicidal Ideation
- Being tested
- Estradiol Transdermal Patch 0.1 mg/24 hrs, Oral Micronized Progesterone 200mg, Inactive Clear Patch, Placebo capsule
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Transdermal Patch 0.1 mg/24 hrsDrug
Also called Climara
Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
Oral Micronized Progesterone 200mgDrug
Also called Prometrium
100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation (200mg total per day)
Inactive Clear PatchDrug
Also called Placebo transdermal patch
Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
Placebo capsuleDrug
Also called Sugar pill
Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Estradiol + Oral Micronized Progesterone | Experimental | 0.1 mg/24hr transdermal estradiol patch applied weekly and 100 mg oral micronized progesterone taken twice daily by mouth, for 14 days starting 7 days after a positive urine luteinizing hormone (LH) test. Receives: Drug: Estradiol Transdermal Patch 0.1 mg/24 hrs; Drug: Oral Micronized Progesterone 200mg; Drug: Inactive Clear Patch; Drug: Placebo capsule |
| Placebo Patch + Placebo Pills | Experimental | Placebo patch (selected to match transdermal estradiol patch) applied weekly and placebo pills (blinded to match oral micronized progesterone) taken twice daily by mouth, for 14 days starting 7 days after a positive urine luteinizing hormone (LH) test. Receives: Drug: Estradiol Transdermal Patch 0.1 mg/24 hrs; Drug: Oral Micronized Progesterone 200mg; Drug: Inactive Clear Patch; Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimenstrual Change in Daily Adult Suicidal Ideation Questionnaire (ASIQ) Scores
The Adult Suicidal Ideation Questionnaire (ASIQ) is a 25-item self-report questionnaire assessing suicidality. Each day, individuals rate each of 25 items on a scale from 1 (Not at All) to 6 (Extreme). Mean scores are computed, providing a single number for each day that represents the participant's mean suicidal ideation (1 to 6), with higher daily values representing more severe suicidal ideation.
Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in suicidal ideation, and negative values represent a perimenstrual decrease.
Measured: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Perimenstrual Change in Daily Columbia Suicide Severity Rating Scale (C-SSRS) Screening Interview Planning Item Scores
The Columbia Suicide Severity Rating Scale is an interview designed to assess various aspects of suicide risk. In the present study, this questionnaire is administered daily via phone interview as part of a risk screening process. Here, we utilize a single dichotomous outcome from a single item representing suicidal planning from the C-SSRS interview: "Today, have you thought about how or when you might kill yourself?". Each day, individuals chose either "Yes" (coded as 1) or "No" (coded as 0).
Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in suicidal planning, and negative values represent a perimenstrual decrease.
Measured: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Secondary outcomes (2)
Perimenstrual Change in Daily Beck Hopelessness Scale (BHS) Short Form Scores
Hopelessness is assessed with a daily Beck Hopelessness Scale (short form), a 10-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 10. Scores provide a measure of the severity of self-reported hopelessness, with higher scores representing greater hopelessness.
Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in hopelessness, and negative values represent a perimenstrual decrease.
Measured: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Perimenstrual Change in Daily Brief Agitation Measure (BAM) Scores
Agitation is assessed with a daily Brief Agitation Measure (BAM), a 3-item self-report measure in which participants rate their symptoms of agitation ranging from 0 (Strongly Disagree) to 6 (Strongly Agree). Mean daily scores (ranging from 0 to 6) provide a measure of the severity of self-reported agitation, with higher scores representing greater agitation.
Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in agitation, and negative values represent a perimenstrual decrease.
Measured: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start15 Sep 2020
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover 2-Condition Placebo-Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tory Anne Eisenlohr-Moul, University of Illinois Chicago
- Investigators
- Tory A Eisenlohr-Moul, Ph.D, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112368
- Sponsor's protocol ID
- 2019-0624
- Acronym
- CLEAR-3
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2019
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach
- ClinicalTrials.gov ID
- NCT04112368
- Acronym / sponsor ID
- CLEAR-3 / 2019-0624
- Conditions
- Suicidal Ideation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cyclical changes in hormones and their metabolites influence short-term risk of suicide. The data acquired will contribute to our understanding of the biology of acute suicide risk and advance efforts to develop safe and effective treatments that eliminate predictable monthly worsening of suicide risk in reproductive-age females.
Detailed description
Suicide is the second leading cause of death among women of reproductive age, and female suicide attempts occur most frequently around menses (perimenstrually), when estradiol (E2) and progesterone (P4) fall rapidly. A recent prospective study demonstrated that suicidal ideation (SI) and attempts peak perimenstrually in natural cycles, and that this perimenstrual worsening of SI can be prevented by administering stabilizing doses of E2+P4 (relative to placebo). Therefore, while E2+P4 withdrawal is a viable model of proximal suicide risk in females with SI, mechanisms are unclear. GABAergic neuroactive steroid metabolites of ovarian hormones (e.g., allopregnanolone), exert potent sedative and antidepressant effects; we hypothesize that acute perimenstrual withdrawal from these hormone metabolites may increase suicide risk by increasing hyperarousal and hopelessness. The long-term objectives of this research are to (1) use the menstrual cycle as a model to probe the proximal mechanisms of suicide, and (2) develop long-term treatments that eliminate hormonal contributions to suicide. The objective of the current work is to use a crossover placebo-controlled trial of E2+P4 stabilization (vs. natural E2+P4 withdrawal under placebo) in the perimenstrual weeks to probe behavioral (hopelessness, hyperarousal) and molecular/genetic (neuroactive steroid levels, mRNA expression for enzymes critical for synthesizing neuroactive steroids) mediators of perimenstrual suicide risk. Design: In this mechanistic trial, 90 female outpatients with past-month SI will complete two counterbalanced conditions: (1) two weeks of placebo during natural perimenstrual E2+P4 withdrawal, and (2) two weeks of perimenstrual E2+P4 stabilization (.1mg/day transdermal estradiol + 200mg/day oral micronized progesterone) to prevent withdrawal. Five labs per condition will capture changes in gas chromatography mass spectrometry (GC-MS) quantified neuroactive steroids, messenger ribonucleic acid (mRNA) expression for enzymes critical for synthesizing neuroactive steroids, and physiological arousal. Our app (BiAffect) will collect ecological momentary assessments (EMA; 4x/day) of behavioral constructs and SI, and will passively track arousal via movement and typing speed instability. Specific Aims. Aim 1 is to evaluate hyperarousal and hopelessness as interacting mechanisms by which perimenstrual E2+P4 withdrawal (vs. experimental E2+P4 stabilization) increases proximal suicide risk. Aim 2 is to evaluate neuroactive steroid withdrawal as a mechanism by which perimenstrual E2+P4 withdrawal (vs. stabilization) increases proximal suicide risk. If appropriate, a multilevel path model will test a path in which E2+P4 withdrawal (vs. stabilization) causes neuroactive steroid withdrawal, which increases in hopelessness and hyperarousal, which in turn increases proximal suicide risk. Relevance. By conducting a mechanistic experiment to probe the mediators of a known cause of proximal suicide risk, the proposed research responds to public calls from the National Institute of Mental Health (NIMH)-sponsored Suicide Research Prioritization Agenda to identify modifiable causes of proximal suicide risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover 2-Condition Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Transdermal Estradiol + Oral Micronized Progesterone | Experimental | Drug: Estradiol Transdermal Patch 0.1 mg/24 hrs, Drug: Oral Micronized Progesterone 200mg, Drug: Inactive Clear Patch, Drug: Placebo capsule0.1 mg/24hr transdermal estradiol patch applied weekly and 100 mg oral micronized progesterone taken twice daily by mouth, for 14 days starting 7 days after a positive urine luteinizing hormone (LH) test. |
| Placebo Patch + Placebo Pills | Experimental | Drug: Estradiol Transdermal Patch 0.1 mg/24 hrs, Drug: Oral Micronized Progesterone 200mg, Drug: Inactive Clear Patch, Drug: Placebo capsulePlacebo patch (selected to match transdermal estradiol patch) applied weekly and placebo pills (blinded to match oral micronized progesterone) taken twice daily by mouth, for 14 days starting 7 days after a positive urine luteinizing hormone (LH) test. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ability to adhere to medication regimen
- Speaks English
- Assigned female at birth with intact ovaries
- Premenopausal
- Normal menstrual cycles between 25-35 days
Key exclusion criteria (6 listed)
- Must not be pregnant, breastfeeding, or trying to become pregnant.
- Must not be taking any form of exogenous hormones or hormonal intrauterine device, and must have ended previous use of hormonal preparations at least one month prior to the study.
- Must not have a personal history of any chronic medical condition, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease, and no personal or first degree family history of thromboembolic events.
- Any current cigarette smoking is exclusionary.
- Must not report a history of clinical diagnosis or treatment for postpartum depression or premenstrual dysphoric disorder (Note: Premenstrual Dysphoric - - - Disorder diagnosis must have been made based on prospective daily ratings).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol Transdermal Patch 0.1 mg/24 hrsAlso: ClimaraEstradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation | Drug | Placebo Patch + Placebo Pills, Transdermal Estradiol + Oral Micronized Progesterone |
| Oral Micronized Progesterone 200mgAlso: Prometrium100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation (200mg total per day) | Drug | Placebo Patch + Placebo Pills, Transdermal Estradiol + Oral Micronized Progesterone |
| Inactive Clear PatchAlso: Placebo transdermal patchMatching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation | Drug | Placebo Patch + Placebo Pills, Transdermal Estradiol + Oral Micronized Progesterone |
| Placebo capsuleAlso: Sugar pillMatching placebo capsules administered twice daily for 14 days starting day 7 after ovulation | Drug | Placebo Patch + Placebo Pills, Transdermal Estradiol + Oral Micronized Progesterone |
Primary outcome
Perimenstrual Change in Daily Adult Suicidal Ideation Questionnaire (ASIQ) Scores
Time frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
The Adult Suicidal Ideation Questionnaire (ASIQ) is a 25-item self-report questionnaire assessing suicidality. Each day, individuals rate each of 25 items on a scale from 1 (Not at All) to 6 (Extreme). Mean scores are computed, providing a single number for each day that represents the participant's mean suicidal ideation (1 to 6), with higher daily values representing more severe suicidal ideation. Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in suicidal ideation, and negative values represent a perimenstrual decrease.
Perimenstrual Change in Daily Columbia Suicide Severity Rating Scale (C-SSRS) Screening Interview Planning Item Scores
Time frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
The Columbia Suicide Severity Rating Scale is an interview designed to assess various aspects of suicide risk. In the present study, this questionnaire is administered daily via phone interview as part of a risk screening process. Here, we utilize a single dichotomous outcome from a single item representing suicidal planning from the C-SSRS interview: "Today, have you thought about how or when you might kill yourself?". Each day, individuals chose either "Yes" (coded as 1) or "No" (coded as 0). Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in suicidal planning, and negative values represent a perimenstrual decrease.
2 secondary outcomes
Perimenstrual Change in Daily Beck Hopelessness Scale (BHS) Short Form Scores
Time frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Perimenstrual Change in Daily Brief Agitation Measure (BAM) Scores
Time frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tory A Eisenlohr-Moul, Ph.D principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol Transdermal Patch 0.1 mg/24 hrs, Oral Micronized Progesterone 200mg and Inactive Clear Patch in people with Suicidal Ideation, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perimenstrual Change in Daily Adult Suicidal Ideation Questionnaire (ASIQ) Scores (time frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.