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 study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	07.04.2022

Trial locations

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.

Investigated diseases:

Breast cancer

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 ID:

2024-510845-33-00

Protocol code:

GRACE

NCT ID:

NCT05562518

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?