← Back to Search

Hormone Therapy

Hormone Withdrawal for Depression (PEAR Trial)

Phase 4

Recruiting

Led By Chris Sikes-Keilp, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again at the first visit of the second condition. Women will be instructed to use a barrier method of birth control during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the course of 2 menstrual cycles (~28 days each), idas will be collected 4 times on 4 separate days: twice during the late luteal phase (11-14 days following ovulation), and twice during the mid follicular phase (23-25 days following ovulation)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

"This trial aims to understand how hormonal changes during the menstrual cycle impact mood symptoms in women with depression that worsens before menstruation. They will investigate how estrogen and progesterone levels affect pleasure and reward

Who is the study for?

This trial is for reproductive-aged women who experience depression that gets worse before their period. They should be generally healthy and not currently pregnant or breastfeeding. Participants must not be on hormonal treatments, have a history of hormone-sensitive cancers, or any serious psychiatric conditions other than depression.

What is being tested?

The study tests how stabilizing hormones during the menstrual cycle affects mood in depressed women. It compares the effects of estradiol patches and progesterone pills against placebos over three cycles, measuring pleasure response and brain activity related to reward.

What are the potential side effects?

Possible side effects include skin irritation from patches, changes in mood or libido due to hormone fluctuations, headache, nausea, and breast tenderness associated with hormone therapy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, nor trying to become pregnant and will use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the course of 2 menstrual cycles (~28 days each), idas will be collected 4 times on 4 separate days: twice during the late luteal phase (11-14 days following ovulation), and twice during the mid follicular phase (23-25 days following ovulation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the course of 2 menstrual cycles (~28 days each), idas will be collected 4 times on 4 separate days: twice during the late luteal phase (11-14 days following ovulation), and twice during the mid follicular phase (23-25 days following ovulation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the course of 2 menstrual cycles (~28 days each), idas will be collected 4 times on 4 separate days: twice during the late luteal phase (11-14 days following ovulation), and twice during the mid follicular phase (23-25 days following ovulation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dimensional Anhedonia Rating Scale (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)

Reward Positivity (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)

Secondary study objectives

Daily Record of Severity of Problems (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)

Inventory for Depression and Anxiety Symptoms (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then Estradiol+ProgesteroneExperimental Treatment4 Interventions

Two weeks of luteal phase transdermal/oral placebo during the first intervention cycle, followed by a one cycle washout, followed by two weeks of luteal phase transdermal estradiol (0.1 mg/day)+oral progesterone (200 mg/day)

Group II: Estradiol+Progesterone, then PlaceboExperimental Treatment4 Interventions

Two weeks of luteal phase transdermal estradiol (0.1mg/day)+oral progesterone (200 mg/day) during the first intervention cycle, followed by a one cycle washout, followed by two weeks of luteal phase transdermal/oral placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

placebo capsule

2011

Completed Phase 4

~4110

Transdermal estradiol

2001

Completed Phase 3

~60