Clinical trial · Interventional
Preventing Sexual Dysfunction With Aromatase Inhibitors
Preventing Sexual Dysfunction in Women on Aromatase Inhibitors
- 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)
Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning after treatment in women who are in menopause and who had breast cancer that was sensitive to the hormone estrogen. The goal of this study is to learn if it is possible to prevent some AI side effects, particularly problems with vaginal dryness and pain during sexual activity. Researchers also want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid vaginal dryness. Researchers want to see if preventing these side effects will decrease the number of women who stop taking AIs due to the side effects they cause.
Conditions
Conditions (1)
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 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education Materials | Other | — | UNRESOLVED |
| Hyalo-Gyn | Other | — | UNRESOLVED |
| Interactive Internet-Based Website | Behavioral | — | UNRESOLVED |
| Luvena | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Telephone Counseling. | Behavioral | — | UNRESOLVED |
| Vaginal Lubricant | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Usual Care + Education Materials
- description
- Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time. Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes. Water-based vaginal lubricant used during sexual activity.
- interventionNames
- Behavioral: Questionnaires
- Other: Education Materials
- type
- EXPERIMENTAL
- label
- Luvena Group
- description
- Luvena used vaginally 2 or 3 times a week. Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time. Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes. Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs. Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of Stage 0 to III breast cancer 2. Age over 18 years 3. Began adjuvant therapy with an aromatase inhibitor 12 to 18 months before survey sent out (Benchmark Survey only) 4. Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past 2 to 4 weeks (Randomized Trial only) 5. Had sexual activity at least once in past 12 months (Randomized Trial Study only) 6. Has been in a stable sexual relationship of at least 6 months' duration (Randomized Trial study only) Exclusion Criteria: 1. Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) during the Randomized Trial study will be excluded 2. Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded 3. Has distant metastases 4. Cannot read or speak English well enough to understand materials and complete questionnaires 5. No access to the internet in a private location
References
Publications (0)
Data not yet available