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New hope for breast cancer survivors: trial tests vaginal treatments for hormone therapy side effects

NCT ID NCT05562518

Symptom relief Sponsor: University Hospital, Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests four different vaginal treatments (estrogen, DHEA, estrogen with probiotics, and a moisturizer) in 160 breast cancer patients who have vaginal atrophy due to hormone therapy. The goal is to see which treatment best relieves symptoms like dryness and pain, and improves quality of life, while monitoring hormone levels for safety. Participants will use the treatments for 12 weeks, and their symptoms and vaginal health will be tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Estrogen, dehydroepiandrosterone (DHEA), probiotics, and moisturizer
What this could lead to
If successful, this trial could identify safe and effective local treatments for vaginal atrophy in breast cancer survivors, improving their comfort and quality of life.
What could go wrong
This is a phase 4 trial with a moderate size (160 participants). The treatments are already approved for other uses, but their safety and effectiveness in this specific group are still being studied. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

31 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * breast cancer patient * current endocrine therapy (AI or SERM) * postmenopausal status, defined by: * 12 months amenorrhoea or * 6 months amenorrhoe and FSH level of \>40 mIU/mL or \*\>6 weeks after bilateral oophorectomy or * induced postmenopause (ovarian function suppression using GnRH-analogue) * presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation) Exclusion Criteria: * a history of vulvar or vaginal surgery (Inclusion is possible after hysterectomy. For these subjects no microbiome sampling will be performed. Microbiome analysis is not performed for these subjects.) * current other vulvar or vaginal disease * recent use of antibiotics/antifungals/corticosteroids (less than 1 month) * current use of vaginal hormonal treatment or vaginal moisturizer: inclusion is possible after a washout period of 4 weeks

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm postmenopausal atrophic vaginitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Vulvovaginal atrophy

Contacts and locations

Locations

  • University Hospital Ghent

    Ghent, 9000, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.