Clinical trial · Interventional
REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy
NCT01984138CI-TRIAL-00101809REVIVEactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Estrogen Receptor Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESTRING | Drug | — | UNRESOLVED |
| Replens | Drug | — | UNRESOLVED |
| Vagifem | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaginal Estrogen
- description
- vaginal estrogen with Estring or Vagifem, per the patient's preference
- interventionNames
- Drug: ESTRING
- Drug: Vagifem
- type
- ACTIVE_COMPARATOR
- label
- REPLENS
- description
- Replens
- interventionNames
- Drug: Replens
Primary outcomes (1)
- measure
- What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.
- timeFrame
- 4.5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.