Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Intervention: Estradiol Transdermal Patch 0.1 mg/24 hrs; Oral Micronized Progesterone; Inactive Clear Patch; Placebo capsule
Intervention description: Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation; 100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation; Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation; Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
Intervention MeSH terms: Estradiol; Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover 2-Condition Placebo-Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Identical placebos provided by the UNC investigational drug service.
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Steroid hormones; Estradiol; Progesterone; Depression; Suicide

Summary:

      This within-person, crossover, 2-condition, placebo-controlled study compares the impact of
      two perimenstrual conditions on severity of suicidal symptoms in females with past-month
      suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) natural
      perimenstrual withdrawal from estradiol and progesterone (during placebo), (2) perimenstrual
      stabilization of estradiol and progesterone using transdermal estradiol and oral micronized
      progesterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  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.

        Exclusion Criteria:

          -  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.