REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy

NCT01984138 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: REVIVE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating whether breast cancer patients who experience vaginal dryness while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal moisturizer called Replens.

Conditions

Estrogen Receptor Positive Breast Cancer; Breast Cancer

Keywords

estrogen receptor positive breast cancer; breast cancer

Outcome Measures

Primary Outcomes (1)

• What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.

  To compare improvement of atrophic vaginitis signs and symptoms between women on the vaginal estrogen ring and those on Replens vaginal cream. 1.1 Administer a questionnaire at baseline, 4 weeks, 12 weeks, and 24 weeks to all patients which will assess vaginal dryness and vaginal itching. Over six months, we expect that patients who are receiving vaginal estrogen will have more improvement in atrophic vaginitis symptoms as compared to those women on Replens.

  4.5 years

Secondary Outcomes (1)

• Compliance of use of Aromatase Inhibitor to assure safety

  4.5 years

Other Outcomes (2)

• EXPLORATORY OBJECTIVE

  5 years

• Evaluation of vaginal dryness by vaginal pH

  6 months from baseline

Study Arms (2)

Vaginal Estrogen

EXPERIMENTAL

vaginal estrogen with Estring or Vagifem, per the patient's preference

Drug: ESTRING; Drug: Vagifem

REPLENS

ACTIVE COMPARATOR

Replens

Drug: Replens

Interventions

ESTRING DRUG

ESTRING (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days. ESTRING has the following dimensions: outer diameter 55 mm; cross-sectional diameter 9 mm; core diameter 2 mm. One ESTRING should be inserted into the upper third of the vaginal vault, to be worn continuously for three months.

Also known as: (estradiol vaginal ring)

Vaginal Estrogen

Replens DRUG

Replens should be applied vaginally, with a supplied applicator, three times each week.

REPLENS

Vagifem DRUG

VAGIFEM: Vagifem (estradiol vaginal tablet) is a small, white round, film-coated, bi-convex vaginal insert, which measures 6 mm. Each vaginal insert contains 10 mcg of estradiol, and it is administered via disposable applicator. The insert is placed vaginally using the applicator, and it will dissolve on its own while releasing estradiol into the local tissues

Also known as: Vagifem (estradiol vaginal tablet)

Vaginal Estrogen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be female
• be 18 years of age or older.
• have stage I-III ER+ breast cancer
• 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.
• currently take adjuvant AI therapy
• have vaginal dryness, dyspareunia, or ≥3 urinary tract infections per year since starting AI therapy
• 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.

You may not qualify if:

• use of any exogenous estrogen within the preceding four weeks
• current vaginal infection.

Sponsors & Collaborators

• Polly A. Niravath, MD: lead

Study Sites (1)

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estradiol; Replens

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Polly Niravath, MD

  Houston Methodist Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: November 14, 2013
• Study Start: September 1, 2013
• Primary Completion: June 3, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)