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Study on Improving Cervical Dysplasia Diagnosis in Postmenopausal Women Using Estradiol

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What is this trial about?

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

This clinical trial focuses on improving the diagnosis of cervical dysplasia, which involves changes in the cells on the surface of the cervix that could potentially lead to cervical cancer. The study is specifically for postmenopausal women aged 50 and above who have tested positive for HPV (Human Papillomavirus) or have shown changes in cervical cells. The treatment being studied is a vaginal tablet containing estradiol, a form of estrogen, which is a hormone that helps maintain the health of vaginal tissues. The trial will compare the effects of this treatment with a placebo, which looks like the real treatment but does not contain the active substance.

The purpose of the study is to see if using vaginal estradiol before a colposcopic examination can improve the diagnosis of precancerous lesions in the cervix. A colposcopy is a procedure where a doctor uses a special magnifying device to look at the cervix more closely. The study will involve participants receiving either the estradiol treatment or a placebo for a short period before their colposcopy. The researchers will then assess the visibility of the cervix during the examination and the representation of cervical tissue in biopsies, which are small samples of tissue taken for closer examination.

Throughout the study, the researchers will also monitor any side effects reported by participants during the pretreatment phase. They will evaluate the presence of more severe cell changes, known as CIN2+, in the biopsies. The study aims to reduce the burden of cervical disease and prevent the progression to cervical cancer by improving diagnostic accuracy. The trial is expected to run until December 2025, with recruitment having started in August 2023.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the criteria: being a postmenopausal woman aged 50 or older, referred for a colposcopy due to a positive HPV test, abnormal cervical cytology, or previous abnormal cervical histology with at least six months since the last colposcopy with biopsies.

  2. Step 2

    Pretreatment phase

    The study involves pretreatment with a vaginal estrogen tablet called Vagifem, which contains 10 micrograms of estradiol. This medication is administered vaginally.

    The purpose of this pretreatment is to potentially improve the diagnosis of cervical precancerous lesions during the colposcopic examination.

  3. Step 3

    Colposcopic examination

    A colposcopic examination is conducted to assess the cervix. The visibility of the squamocolumnar junction (SCJ) is scored by the colposcopist as TZ1, TZ2, or TZ3.

    Cervical biopsies are taken, and at least 25% of these biopsies should represent the transformation zone (TZ) as described by the pathologist.

  4. Step 4

    Evaluation of outcomes

    Primary outcomes include the visibility scoring of the SCJ and the representation of the TZ in cervical biopsies.

    Secondary outcomes involve reporting any side effects during pretreatment, the proportion of CIN2+ found in biopsies, the proportion of diagnostic conization, and comparing the severity of histopathologic results among biopsies.

Who can join the trial?

6 criteria

  • Women who are **50 years or older** and have gone through **menopause**. Menopause is when a woman stops having her monthly periods.
  • Women who have been sent for a **colposcopy**. A colposcopy is a special examination of the cervix, which is the lower part of the uterus.
  • Women who have a **positive HPV test**. HPV is a virus that can cause changes in the cervix.
  • Women who have **abnormal cervical cytology**. This means there are unusual cells found in the cervix.
  • Women who have had **abnormal cervical histology** in the past. This means there were unusual cells found in a previous test of cervical tissue.
  • It must be at least **6 months** since their last colposcopy with biopsies. A biopsy is when a small piece of tissue is taken to be checked under a microscope.

Who cannot join the trial?

4 criteria

  • Patients who are not **HPV positive**. HPV stands for Human Papillomavirus, a common virus that can cause changes in cervical cells.
  • Patients who do not have cervical cell changes or **dysplasia**. Dysplasia refers to abnormal changes in the cells on the surface of the cervix.
  • Patients who are not postmenopausal women aged 50 years or older. Postmenopausal means women who have stopped having menstrual periods.
  • Patients who are not female, as the study is only for women.
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Investigated drugs

Vaginal Estrogen is used in this study to see if it can improve the diagnosis of cervical precancerous lesions in postmenopausal women. The medication is applied before a colposcopic examination, which is a procedure to closely examine the cervix for signs of disease. The goal is to see if using vaginal estrogen can make it easier to identify these lesions, potentially reducing the risk of developing cervical cancer.

What is already known about the treatment

Vaginal Estrogen – This medication is administered in the form of a cream, tablet, or ring that is applied directly to the vaginal area. It is currently being studied in clinical trials to assess its effectiveness in improving the diagnosis of cervical precancerous lesions, particularly in postmenopausal women aged 50 years and older. The main therapeutic indication is to enhance the accuracy of colposcopic examinations by pretreating with vaginal estrogen, potentially reducing the risk of cervical cancer. At the molecular level, vaginal estrogen works by replenishing estrogen levels in the vaginal tissue, which can help restore normal cell function and structure. It is classified pharmacologically as a hormone replacement therapy.

Investigated diseases

  • Human Papillomavirus (HPV) Infection

    This is a viral infection that affects the skin and moist membranes lining the body, such as the cervix, anus, mouth, and throat. It is often transmitted through intimate skin-to-skin contact. Many people with HPV do not develop symptoms, but some types can cause warts or lead to precancerous changes in the cervix. Over time, persistent infection with high-risk HPV types can lead to cervical dysplasia, which is a precancerous condition. The progression from HPV infection to cervical dysplasia can vary, with some cases resolving on their own and others progressing to more severe changes.

  • Cervical Dysplasia

    This condition involves abnormal changes in the cells on the surface of the cervix. It is often caused by persistent infection with high-risk types of HPV. Cervical dysplasia is classified into different grades based on the extent of abnormal cell growth, ranging from mild to severe. While mild dysplasia may resolve without treatment, severe dysplasia can progress to cervical cancer if left untreated. The condition is typically detected through routine cervical screening tests, such as Pap smears.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517151-12-00Estimated enrolment150 patientsSponsorRegion Midtjylland

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