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

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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.

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
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)
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
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)
check
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)
- check
  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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Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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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

Since no specific medications are mentioned in the provided clinical trial data, I cannot create medication descriptions in the requested format. The trial appears to be about comparing different treatments for vulvovaginal atrophy in breast cancer patients who are on endocrine therapy (AI or SERM), but the specific medications being studied are not listed in the provided data. If you would like medication descriptions, please provide the specific medications involved in the trial, and I will create descriptions following the requested format: Medication Name – description format.

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.