Clinical trial · Interventional
Vaginal DHEA for Women After Breast Cancer
Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy
NCT01724242CI-TRIAL-00030551withdrawnPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to recruit patients
Summary
Brief summary (as posted)
There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.
Conditions
Conditions (5)
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 |
| Quality of Life | — | UNRESOLVED | — |
| Sexual Satisfaction | — | UNRESOLVED | — |
| Urinary Incontinence | — | UNRESOLVED | — |
| Vaginal Dryness | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vaginal DHEA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaginal DHEA
- description
- Vaginal DHEA 0.5%(6.5mg)inserted nightly
- interventionNames
- Drug: Vaginal DHEA
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- improvement in vaginal dryness
- timeFrame
- 12 weeks
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed. Exclusion Criteria: * women using products to alleviate vaginal dryness. * women taking medication for urinary incontinence * women not sexually active, for other reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.