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Comparison of estriol, prasterone and estriol with lactobacillus for vulvovaginal atrophy in breast cancer patients on endocrine therapy

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on treating vulvovaginal atrophy, a condition causing vaginal dryness and discomfort, in women with breast cancer who are receiving endocrine therapy. The treatments being tested include different vaginal medications: Oekolp (containing estriol), Gynoflor (containing estriol and lactobacillus), and Intrarosa (containing prasterone). These medications are applied directly in the vagina as tablets or pessaries.

The purpose of this research is to compare how well these different treatments work in improving symptoms of vulvovaginal atrophy and to ensure they are safe for breast cancer patients. The study will last 12 weeks, during which participants will receive one of the vaginal treatments. The treatments are designed to help improve vaginal health and reduce discomfort associated with vaginal dryness.

Throughout the study, researchers will monitor changes in vaginal health and collect information about symptom improvement using questionnaires. They will also check blood samples to measure hormone levels and ensure the treatments are safe for breast cancer patients. All medications used in this study are already approved for medical use.

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

    Initial assessment

    Your participation begins with completing two questionnaires: the EQ5D and FACT-ES to evaluate your symptoms

    A blood sample will be collected to measure hormone levels

    Clinical evaluation includes measuring vaginal pH and examining vaginal tissue samples

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of the following medications for vaginal use:

    - Oekolp (contains estriol)

    - Gynoflor (contains estriol and lactobacillus)

    - Intrarosa (contains prasterone 6.5 mg)

  3. Step 3

    6-week assessment

    After 6 weeks of treatment, you will complete the same questionnaires again

    Another blood sample will be collected

    Clinical evaluation will be repeated to assess treatment progress

  4. Step 4

    Final assessment

    The final evaluation occurs after 12 weeks of treatment

    You will complete the EQ5D and FACT-ES questionnaires one last time

    A final blood sample will be collected

    Final clinical evaluation will be performed to assess overall treatment results

Who can join the trial?

10 criteria

  • You must be a female patient diagnosed with breast cancer
  • You must be currently receiving endocrine therapy (taking medications known as AI - aromatase inhibitors or SERM - selective estrogen receptor modulators)
  • You must be postmenopausal, which means one of these conditions:
    • No menstrual periods for 12 months, or
    • No menstrual periods for 6 months and specific hormone level (FSH) above 40 mIU/mL, or
    • Surgically induced menopause (removal of both ovaries), or
    • Medically induced menopause using specific medications (GnRH-analogues)
    • You must have at least one of these vaginal symptoms:
      • Pain during sexual intercourse (dyspareunia)
      • Vaginal dryness
      • Vaginal irritation
      • You must be an adult woman (18 years or older)

Who cannot join the trial?

13 criteria

  • Current diagnosis of metastatic breast cancer (cancer that has spread to other parts of the body)
  • Presence of vaginal infections or other active vaginal conditions requiring treatment
  • Use of vaginal treatments or medications in the past 4 weeks
  • History of severe allergic reactions to any of the study medications
  • Participation in another clinical trial within the last 30 days
  • Pregnancy or planning to become pregnant during the study period
  • Breastfeeding women
  • Uncontrolled medical conditions that could interfere with the study
  • Previous radiation therapy to the pelvic area within the last 6 months
  • Current use of medications that could interact with the study treatment
  • Unable to follow study procedures or attend scheduled visits
  • History of hormone-dependent tumors other than breast cancer
  • Significant abnormal findings during the initial gynecological examination
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Investigated drugs

  • Prasterone

    is a drug used to treat vaginal dryness and other vaginal symptoms associated with aging. In this study, it is used in breast cancer patients receiving hormone therapy.

  • Estriol

    is an estrogen hormone used to treat vaginal dryness and menopausal symptoms. It helps keep vaginal tissues healthy and reduces discomfort.

  • Hyaluronic acid

    is a substance that helps moisturize and lubricate the vagina. It is often used as a non-hormonal alternative for treating vaginal dryness.

What is already known about the treatment

  • Oekolp 0.03 mg, ovules

    This medication is a small vaginal pessary that contains estriol, a weak form of estrogen, and is inserted into the vagina. It is an approved treatment in several countries for relieving vaginal dryness and thinning that can occur in women on endocrine therapy. Estriol works by attaching to estrogen receptors in the vaginal lining, helping the tissue stay moist and healthy. It is classified as an estrogenic hormone preparation.

  • Gynoflor Vaginal tablets

    These are vaginal tablets that combine estriol with lyophilized Lactobacillus acidophilus, and they are placed inside the vagina. The product is used to treat vaginal atrophy and discomfort in women, especially those receiving breast cancer endocrine therapy. Estriol restores the vaginal lining by activating estrogen receptors, while the probiotic bacteria help maintain a healthy vaginal flora. It belongs to the class of estrogen‑probiotic combination therapies.

  • Intrarosa 6.5 mg pessary

    This medication is a vaginal pessary that delivers prasterone, also known as dehydroepiandrosterone (DHEA), directly to the vaginal tissue. It is approved for treating vulvovaginal atrophy in post‑menopausal women and is being studied for safety in breast cancer patients on hormonal treatment. Prasterone is converted inside cells to local estrogen and androgen compounds, which thicken and lubricate the vaginal lining without raising blood hormone levels much. It is classified as a locally acting steroid hormone (DHEA) preparation.

Investigated diseases

  • Breast Cancer

    A disease where cells in the breast tissue begin to grow abnormally and divide uncontrollably. It typically starts in the ducts or lobules of the breast tissue. The disease can develop over time as cells continue to multiply and form a mass or tumor. It can affect both women and men, though it's much more common in women.

  • Vulvovaginal Atrophy

    A condition that occurs when there is a decrease in estrogen levels, causing the vaginal tissues to become thinner, drier, and less elastic. This natural process often develops during and after menopause or as a side effect of certain medical treatments. The condition can cause discomfort and changes in the vaginal environment, including increased pH levels and changes in the vaginal cell composition.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510845-33-00Protocol codeGRACEEstimated enrolment190 patientsSponsorUniversitair Ziekenhuis Gent

sourced from the EU Clinical Trials Register and site verification

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