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Can vaginal estrogen be safe for breast cancer survivors? new study investigates

NCT ID NCT00984399

Knowledge-focused Sponsor: Memorial Sloan Kettering Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a low-dose vaginal estrogen tablet (Vagifem) is safe for women who have had breast cancer and are taking aromatase inhibitors. 31 postmenopausal women with a history of breast cancer used the tablet for vaginal dryness. Researchers measured their blood estrogen levels to see if the estrogen gets absorbed into the bloodstream, which could potentially raise cancer risk.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

31 people

The number who actually took part.

Started

Sep 2009

Finished

May 2024

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: * History of breast cancer, stages I-III with pathology confirmed at MSKCC * Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease. * Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole * Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence * Menopausal at study entry defined as: * Bilateral salpingo-oophorectomy independent of age * If natural menopause, age ≥ 50 with cessation of menses for at least 12 months * If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished * At least 18 years of age * Able to participate in the informed consent process * Gynecology examination within six months * Able to read/speak English Exclusion Criteria: * Inability to give informed consent * Vaginal bleeding of unknown etiology within 12 months of study entry * History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm postmenopausal atrophic vaginitis vaginitis

As listed by the trial registrant

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

Atrophic vaginitis Breast cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital

    Sleepy Hollow, New York, United States

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York, United States

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