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Effect of Stopping Ethinylestradiol/Levonorgestrel Contraceptive on Mood and Memory in Adults with Major Depressive Disorder on Antidepressant Combination

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What is this trial about?

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

The trial focuses on adults diagnosed with Major Depressive Disorder who are also using a combined oral contraceptive pill. The contraceptive contains two hormones, ethinylestradiol and levonorgestrel. In addition, participants receive standard antidepressant medicines, typically a dose of sertraline or duloxetine taken by mouth.

The purpose of the study is to determine whether stopping the birth control pill influences how well depression improves and how well short‑term memory works while taking antidepressants. Participants are randomly assigned to either continue the pill or switch to a non‑active pill (placebo) for about eight weeks. All participants keep taking their antidepressant medication throughout the period.

During the eight‑week period, participants complete simple questionnaires that rate mood severity and perform brief word‑recall tests that measure the ability to remember spoken words. These checks are done at the start and at the end of the study to compare any changes between the two groups.

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

    Baseline assessment and randomization

    After joining the study, a baseline evaluation is performed. this includes a clinical interview, questionnaires, and memory tests to record the current level of depression and cognitive function.

    Based on the baseline data, the participant is randomly assigned to either continue taking the combined oral contraceptive (femicept) or to discontinue it and receive a matching placebo.

  2. Step 2

    Initiation of study medication

    The participant continues the previously prescribed antidepressant, which is either sertraline 200 mg taken by mouth once daily or duloxetine 120 mg taken by mouth once daily. the dose and schedule remain unchanged for the duration of the trial.

    If assigned to the continuation group, the participant takes one femicept tablet (containing ethinylestradiol and levonorgestrel) of 2 U orally each day.

    If assigned to the discontinuation group, the participant stops the combined oral contraceptive and instead takes one placebo tablet of 2 U orally each day.

  3. Step 3

    Regular study visits

    The participant attends scheduled visits at week 2, week 4, and week 8 after starting the study medication.

    At each visit, the clinician records the hamilton depressive rating scale (6‑item version) score, administers the verbal affective memory task 24 (VAMT‑24) to assess memory performance, and checks adherence to the medication regimen.

    Any side effects or changes in health are documented during these visits.

  4. Step 4

    Primary outcome assessment at week 8

    At the week 8 visit, the main study measurements are completed.

    The average score of the hamilton depressive rating scale and the average recall score of the verbal affective memory task 24 are calculated and recorded as the primary outcomes of the trial.

  5. Step 5

    Study completion and final evaluation

    After the week 8 assessment, the participant may have additional follow‑up visits as defined by the study protocol to monitor longer‑term effects, but no further medication changes are required beyond the study period.

Who can join the trial?

5 criteria

  • Female biological sex – you must be biologically born as a female.
  • Age between 18 and 39 years – you must be at least 18 years old but not older than 39.
  • Currently using combined oral contraception (a birth‑control pill that contains both estrogen and progestin) and have been taking it for at least one month before joining the study.
  • Diagnosed with a moderate to severe unipolar depressive episode according to the ICD‑10 classification (ICD‑10 is an international system doctors use to define illnesses; “unipolar” means depression without any manic episodes, and “moderate to severe” indicates noticeable and strong symptoms).
  • Your doctor must consider treatment with an SSRI monotherapy appropriate (SSRI stands for selective serotonin reuptake inhibitor, a common type of antidepressant, and “monotherapy” means using only this single medication).

Who cannot join the trial?

19 criteria

  • Having thoughts of killing yourself or planning suicide (acute suicidality).
  • Depression that has lasted longer than two years (depressive episode exceeding 2 years).
  • Having a serious physical illness or a serious brain injury (severe somatic disease or traumatic brain injury).
  • Being pregnant, breastfeeding, or planning to become pregnant in the next three months.
  • Being in menopause, the transition to menopause, or using hormone replacement medicine.
  • Not being able to understand Danish well enough to complete memory and questionnaire tests.
  • Having a medical reason that makes taking the drug Femicept unsafe.
  • Having certain women’s health problems that usually need birth‑control pills, such as endometriosis, very painful periods, severe acne, heavy bleeding that causes anemia, or polycystic ovary syndrome.
  • Having a reason you cannot have an MRI, such as metal in the body or a fear of closed spaces (contraindications for MRI).
  • Having been part of a study or job that exposed you to a high level of radiation in the past year (radiation exposure >10 mSv).
  • Taking prescription medicines that affect serotonin (the brain chemical), such as sertraline or other antidepressants, within the last two months.
  • Having been diagnosed with schizophrenia or having symptoms like hearing voices or losing touch with reality (psychosis).
  • Having a problem with alcohol or drug use (substance use disorder).
  • Having another mental health condition that needs treatment other than SSRIs (a common type of antidepressant).
  • Having a medical reason that makes taking sertraline or duloxetine unsafe.
  • Currently taking an antidepressant other than sertraline, or receiving therapy that counts as antidepressant treatment.
  • Having used sertraline for more than one month before joining the study.
  • Having tried another antidepressant drug during this current period of depression.
  • Having been found not to respond to SSRIs (a common type of antidepressant) in the past.
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Investigated drugs

  • Sertraline

    is an antidepressant that people in the study were already taking. It works by increasing certain chemicals in the brain that help improve mood. In this trial, sertraline is used as a background medication, meaning all participants continue their regular dose while the researchers test the effect of changing the birth‑control pill.

  • Duloxetine

    is another type of antidepressant that some participants were using. It helps relieve symptoms of depression by affecting brain chemicals involved in mood and pain. Like sertraline, duloxetine is continued unchanged during the study and serves as a background treatment while the impact of the birth‑control pill is examined.

  • Femicept

    is a combined oral contraceptive pill that contains two hormones: ethinylestradiol (an estrogen) and levonorgestrel (a progestin). In this study, the pill is the test medication. Researchers compare what happens when participants keep taking Femicept (continuation) versus when they stop taking it (discontinuation) to see how this affects their depression treatment results and memory performance.

What is already known about the treatment

  • Sertraline

    taken as a tablet by mouth, it is an approved antidepressant widely used and well studied; it is mainly prescribed for major depressive disorder and other mood conditions; it works by increasing the level of serotonin in the brain by blocking its re‑uptake into nerve cells; it belongs to the class of selective serotonin reuptake inhibitors (SSRIs).

  • Duloxetine

    taken as an oral tablet, this drug is an approved treatment for depression and also for nerve pain, and it has extensive clinical data; it helps relieve symptoms by blocking the re‑uptake of both serotonin and norepinephrine, two chemicals that affect mood and pain; it is classified as a serotonin‑norepinephrine reuptake inhibitor (SNRI).

  • Placebo

    taken as an oral tablet that contains no active drug, it is used in trials to mimic the experience of taking a medicine while having no therapeutic effect; it serves as a control to compare the real treatments; it has no mechanism of action because it contains no active ingredients; it is not a medication but a neutral comparator.

  • Femicept (ethinylestradiol/levonorgestrel)

    taken as a coated oral tablet, this combined hormonal pill is an approved contraceptive that contains estrogen (ethinylestradiol) and progestin (levonorgestrel); it works by preventing ovulation and making the uterine lining less suitable for pregnancy; it belongs to the class of combined oral contraceptives; it is widely used and well documented in medical literature.

Investigated diseases

Major Depressive Disorder - Major Depressive Disorder is a mental health condition marked by a consistently low mood, loss of interest in usual activities, and reduced energy. It often starts slowly, with symptoms becoming more noticeable over weeks or months. Over time, changes in sleep, appetite, and concentration may intensify, making daily tasks harder to manage. The condition can show periods of slight improvement that are followed by further worsening. If left unaddressed, the symptoms may become increasingly entrenched, affecting overall functioning.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526314-90-00Estimated enrolment106 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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