AuthorisedTherapeutic confirmatory (Phase III)Interventional

Vaginal administration of selective estrogen receptor modulator (Tamoxifen) treatment to improve sexual function for women with breast cancer. A randomized, double-blinded, placebo controlled longitudinal phase 3 study.

This study is for women with breast cancer who are experiencing symptoms like vaginal dryness and discomfort, often called vulvovaginal atrophy. Researchers want to see if a vaginal cream containing a medicine called tamoxifen can improve these symptoms and help with sexual function. It’s a carefully designed study where some women will get the tamoxifen cream and others a dummy cream (placebo), without knowing which they are receiving. This helps the researchers find out if tamoxifen is truly effective. The study focuses on how these treatments affect women's sexual health and overall quality of life.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Uppsala University

Enrolment target

120

Start

30 Aug 2024

Vulvovaginal atrophy symptoms

What is this study about?

Many women who have had breast cancer treatment can experience uncomfortable symptoms like vaginal dryness, itching, and pain, especially during sex. This condition is often called vulvovaginal atrophy, and it can significantly impact a woman's quality of life and sexual health. These symptoms are often caused by changes in hormone levels after breast cancer treatment.

This particular study is designed to investigate if a specific medicine, tamoxifen, when applied directly in the vagina as a cream, can help relieve these symptoms. Tamoxifen is already a well-known medicine used in breast cancer treatment, but this study explores its use in a different way, directly where the symptoms are located. The hope is that by targeting the vagina, it can help improve comfort and sexual function for women without affecting their breast cancer treatment.

The study is set up to be very thorough and fair. It's a 'randomized' study, meaning participants are randomly assigned to either receive the tamoxifen cream or a 'placebo' cream (a cream that looks and feels the same but contains no active medicine). It's also 'double-blinded,' which means neither the participants nor their doctors will know who is getting the active medicine and who is getting the placebo. This helps ensure that any observed improvements are genuinely due to the treatment being tested, rather than other factors.

Key takeaways

The study tests a vaginal cream with tamoxifen for breast cancer survivors with vaginal dryness.
It aims to improve sexual health and overall well-being.
Participants will use a cream and complete questionnaires.
It's a 'blinded' study, so you won't know if you're getting the active or dummy cream.
You must be a woman aged 18 or over, experiencing relevant symptoms.
You can stop participating at any time.

Who may be eligible?

This study is looking for women who are 18 years old or older. There is no upper age limit for taking part.

To be eligible, you must be experiencing symptoms of vulvovaginal atrophy. These are common symptoms like vaginal dryness, irritation, itching, or painful sex, often linked to hormone changes. You must also be a woman who has had breast cancer.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Are you experiencing symptoms like vaginal dryness, irritation, or painful sex?
Have you had breast cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the active study cream (tamoxifen) or a dummy cream to use vaginally for a period of time. You will not know which one you are receiving. Over the course of the study, you will be asked to complete several questionnaires at different times. These questionnaires will ask about your vaginal symptoms, your sexual function, and your overall quality of life. This helps the researchers understand if the treatment is making a difference and how it affects your daily life. The study will last for a specific duration, but the detailed follow-up schedule and total duration will be fully explained to you before you agree to participate.

Potential risks and benefits

Taking part in this study could potentially improve your vaginal symptoms and sexual enjoyment if the tamoxifen cream is effective. However, as with any medication, there's a chance you might experience side effects, though the study aims to understand these thoroughly. You will have full support from the study team throughout, and you are free to withdraw from the study at any time without giving a reason, which will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is vulvovaginal atrophy?

It's a condition where the vaginal tissues become thinner, drier, and less elastic, often causing discomfort, itching, and pain during sex. It's common in women after breast cancer treatment.

What is tamoxifen?

Tamoxifen is a well-known medicine used in breast cancer treatment. In this study, it's being tested as a cream applied directly to the vagina to help with symptoms like dryness.

What does 'randomized, double-blinded' mean?

It means you'll be randomly assigned to get either the active cream or a dummy cream, and neither you nor your doctor will know which one you're using. This makes the study results more reliable.

How will my progress be measured?

You'll answer regular questionnaires about your symptoms, sexual health, and how you're feeling overall. This helps the researchers see if the treatment is making a difference.

Can I stop being in the study if I change my mind?

Yes, you can leave the study at any point without it affecting your usual medical care.