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Can a vaginal ring or moisturizer ease dryness for breast cancer survivors?

NCT ID NCT01984138

Symptom relief Sponsor: Polly A. Niravath, MD 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at two treatments for vaginal dryness in women with estrogen receptor-positive breast cancer who are taking aromatase inhibitors. One group uses a vaginal estrogen ring that releases a low dose of estrogen over 90 days, while the other uses a non-hormonal vaginal moisturizer called Replens. The goal is to see which option better improves symptoms like dryness and itching, and whether it affects hormone therapy compliance. The trial enrolled 33 postmenopausal women and tracked their symptoms over six months.

What this could mean

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

Active substance
estradiol vaginal ring (ESTRING) and Replens vaginal moisturizer
What this could lead to
If it works, this could offer a safe way to ease vaginal dryness and improve quality of life for breast cancer survivors on hormone therapy.
What could go wrong
This is a small, early-phase study with only 33 participants, so results may not apply to everyone. Vaginal estrogen might raise estrogen levels slightly, which could be a concern for hormone-sensitive cancers.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Start date

Sep 2013

Expected to finish

Jun 2026

An estimate. End dates often move.

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: 1. be female 2. be 18 years of age or older. 3. have stage I-III ER+ breast cancer 4. be post-menopausal as defined by any of the following: age \>55 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy. 5. currently take adjuvant AI therapy 6. have vaginal dryness, dyspareunia, or ≥3 urinary tract infections per year since starting AI therapy 7. Patients must agree not to use any additional estrogen during the five year study period. However, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed. Exclusion Criteria: 1. use of any exogenous estrogen within the preceding four weeks 2. current vaginal infection.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer postmenopausal atrophic vaginitis

As listed by the trial registrant

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

Breast cancer Estrogen-receptor-positive breast cancer

Contacts and locations

Locations

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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