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Study on Using Estradiol to Prevent Postpartum Depression in Women with a History of the Condition

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on postpartum depression, a type of depression that can occur after childbirth. The treatment being studied is a short-term use of the female sex hormone estradiol, which is delivered through a transdermal patch called Vivelle Dot. This patch releases a controlled amount of estradiol into the body over a 24-hour period. The study also involves a placebo, which is a substance with no active medication, to compare the effects of estradiol.

The purpose of the study is to see if using estradiol shortly after giving birth can help prevent depressive episodes in women who have previously experienced postpartum depression. Participants will receive either the estradiol patch or the placebo for a short period, from the day of birth up to 21 days postpartum. The study will monitor the participants for signs of depression from two weeks to six months after giving birth.

This research aims to provide insights into whether estradiol can be an effective strategy to prevent postpartum depression in women who are at high risk. By comparing the outcomes between those using the estradiol patch and those using the placebo, the study seeks to determine the potential benefits of this hormone treatment in managing postpartum mental health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to evaluate if short-term administration of estradiol can prevent depressive episodes in women with a history of postpartum depression.

  2. Step 2

    Receiving the treatment

    You will receive a transdermal patch called Vivelle Dot 100 microgram/24 hours. This patch contains estradiol and is designed to release the medication through your skin.

    The patch should be applied to your skin and replaced every 24 hours. This treatment will continue from the day of delivery (day 0) to day 21 postpartum.

  3. Step 3

    Placebo group

    If you are in the placebo group, you will receive a hydrocolloid dressing called Comfeel Plus Transparent. This dressing does not contain active medication and is used to compare results with the estradiol group.

    The placebo dressing should also be applied and replaced every 24 hours, from day 0 to day 21 postpartum.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your mental health will be monitored. This includes assessments to check for any signs of depression according to the DSM-V criteria, which is a standard classification of mental disorders.

    These assessments will occur between 2 weeks and 6 months after giving birth.

  5. Step 5

    End of participation

    Your participation in the study will conclude after the final assessment, which takes place up to 6 months postpartum.

    The study is expected to end by December 31, 2025.

Who can join the trial?

4 criteria

  • Must be a woman between the ages of 18 and 45.
  • Must be pregnant in the third trimester.
  • Must have a history of perinatal depression, which means experiencing depression during pregnancy or within six months after giving birth.
  • Must have had a previous depressive episode during pregnancy or within six months after birth, or an untreated depressive episode as assessed by a healthcare professional through a retrospective interview.

Who cannot join the trial?

8 criteria

  • Participants must not have any other serious medical conditions that could interfere with the study.
  • Participants must not be currently taking any medications that could affect the study results.
  • Participants must not have a history of severe allergic reactions to medications.
  • Participants must not be currently participating in another clinical trial.
  • Participants must not have a history of substance abuse or addiction.
  • Participants must not have any psychiatric disorders other than postpartum depression.
  • Participants must not be pregnant again during the study period.
  • Participants must not have any condition that, in the opinion of the study doctor, makes participation unsafe.
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Investigated drugs

Estradiol is a form of estrogen, which is a hormone that plays a key role in the female reproductive system. In this clinical trial, estradiol is being used to see if it can help prevent postpartum depression in women who have had this condition before. The idea is that by giving estradiol shortly after childbirth, it might help stabilize mood and prevent the onset of depression during the postpartum period. This is important because hormonal changes after giving birth can sometimes lead to mood disorders, and estradiol might help balance these changes.

What is already known about the treatment

Estradiol – Estradiol is administered in the form of a short-term treatment, typically as a pill or patch, and is applied during the immediate postpartum period, from day 0 to day 21. It is currently being studied in clinical trials to assess its effectiveness in preventing postpartum depression in women who have previously experienced this condition. The main therapeutic indication for estradiol in this context is to prevent depressive episodes following childbirth. At the molecular level, estradiol works by interacting with estrogen receptors in the brain, which can influence mood and emotional regulation. It is classified pharmacologically as an estrogen hormone.

Investigated diseases

Perinatal depression with postpartum onset – This condition occurs in women after childbirth and is characterized by feelings of extreme sadness, anxiety, and exhaustion that may interfere with a woman's ability to care for herself or her family. It typically begins within the first few weeks after delivery but can start anytime within the first year postpartum. The progression involves persistent depressive symptoms that can include mood swings, irritability, and difficulty bonding with the baby. Women may experience changes in sleep patterns, appetite, and energy levels. The condition can affect daily functioning and the ability to perform routine tasks. It is important to recognize that these symptoms are more intense and last longer than the "baby blues," which are common and usually resolve within a few days postpartum.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518028-63-00Protocol code2020-001592-33Estimated enrolment220 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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