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Study on the Effect of Prasterone on Genitourinary Syndrome in Postmenopausal Women with a History of Breast Cancer or Undergoing Anti-Hormonal Therapy

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment for women who are experiencing symptoms related to menopause and have a history of breast cancer or are currently undergoing treatment for breast cancer. The treatment being tested is a hormonal therapy using a product called Intrarosa, which is a pessary containing the active substance prasterone. This treatment is designed to help improve symptoms such as discomfort in the vaginal, vulvar, or urinary areas, which are collectively known as genitourinary syndrome.

The purpose of the study is to determine if the use of Intrarosa can lead to an improvement in these symptoms for women who have been affected by breast cancer. Participants in the study will receive either the Intrarosa treatment or a placebo. The study will monitor changes in symptoms over a period of time to assess the effectiveness of the treatment. The study will also look at how these symptoms affect the quality of life, including aspects like sexual function and mood.

Throughout the study, participants will undergo regular evaluations to track any changes in their symptoms and overall health. This will include assessments of vaginal health and hormone levels. The study aims to provide valuable information on how Intrarosa can help manage symptoms associated with menopause in women with a history of breast cancer, potentially improving their quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will have already signed a written informed consent form. This indicates understanding and agreement to participate in the trial.
The patient must have a confirmed diagnosis of breast cancer that has been completely removed and must not have any distant metastasis.
Step 2
Initial assessment
An initial assessment will be conducted to confirm the presence of moderate to severe symptoms of genitourinary syndrome, which affect the quality of life.
A gynecological examination will be performed to identify clinical signs of vulvovaginal atrophy.
Step 3
Treatment administration
The patient will begin treatment with Intrarosa 6.5 mg pessary, which contains the active substance prasterone.
The pessary is administered via vaginal use. The frequency and duration of administration will be specified by the study protocol.
Step 4
Ongoing assessments
Throughout the trial, the patient will undergo regular assessments to monitor the subjective improvement of genitourinary symptoms.
These assessments will include gynecological evaluations, use of validated scales such as the Vaginal Health Index, and determination of the maturation index on vaginal cytology.
Step 5
Serum estradiol measurement
Serum estradiol levels will be measured at set intervals before, during, and after the treatment to monitor hormonal changes.
Step 6
Completion of the trial
The trial is estimated to end by July 1, 2026. Upon completion, the patient will have contributed to understanding the role of hormonal vaginal therapy in improving symptoms related to genitourinary syndrome in menopausal women with a history of breast cancer.

Who can join the trial?

10 criteria

Must be a woman who has gone through menopause naturally, through surgery, or due to treatment.
Must have had breast cancer that was confirmed by a test and completely removed, classified as TNM stages I to III.
Must have signed and dated a written agreement to participate in the study.
Must have breast cancer that is either ER negative or has positive hormone receptors and is being treated with an aromatase inhibitor, with or without LHRHa (a type of hormone therapy).
Must not have any signs of cancer spreading to distant parts of the body (not in TNM stage IV).
Must have moderate to severe symptoms of genitourinary syndrome, which affect quality of life, and a vaginal health index (VHI) score of less than 15. The VHI is a measure of vaginal health.
Must show clinical signs of vulvovaginal atrophy, which is thinning and drying of the vaginal walls, during a gynecological exam.
Must have normal kidney and liver function.
Must have a negative Papanicolau (Pap) Smear Cytology Test within one year before joining the study. This test checks for abnormal cells in the cervix.
Must be a woman who has or wants to have sexual intercourse.

Who cannot join the trial?

5 criteria

Women who are not postmenopausal. This means women who have not yet gone through menopause, which is when menstrual periods permanently stop.
Women who have not had breast cancer before or are not currently receiving treatment to lower estrogen levels. Estrogen is a hormone that can affect certain types of breast cancer.
Women who do not have bothersome symptoms related to the vulva, vagina, or urinary system. These symptoms are part of what is called the **genitourinary syndrome**.
Men cannot participate in this study.
Individuals who are considered part of a vulnerable population, which means people who might need special protection or care, are not eligible.

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Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

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Investigated drugs

Prasterone: This medication is used in the trial to help improve genitourinary symptoms in women who are in menopause and have had breast cancer or are currently being treated for breast cancer. Prasterone is administered intravaginally, meaning it is applied directly inside the vagina. It is intended to alleviate symptoms such as vaginal dryness, irritation, and discomfort, which are common in women undergoing menopause and can be exacerbated by breast cancer treatments.

Prasterone

What is already known about the treatment

Prasterone – Prasterone is administered intravaginally, typically in the form of a suppository. It is currently being studied for its effects on genitourinary syndrome in postmenopausal women who have had breast cancer or are undergoing anti-estrogen therapy. The main therapeutic indication is to alleviate bothersome symptoms related to the vulva, vagina, or urinary tract. At the molecular level, Prasterone acts by converting into active sex hormones, which help restore the vaginal tissue's natural function and structure. It is classified pharmacologically as a steroid hormone.

Investigated diseases

Genitourinary Syndrome of Menopause – This condition affects postmenopausal women, particularly those who have had breast cancer or are undergoing anti-estrogen therapy. It involves a range of symptoms affecting the vulva, vagina, and urinary tract. Common symptoms include dryness, burning, irritation, and discomfort during intercourse. The syndrome progresses as estrogen levels decrease, leading to thinning and inflammation of the vaginal walls. This can result in urinary symptoms such as urgency, frequency, and recurrent infections. The condition can significantly impact quality of life, including sexual function and emotional well-being.