Clinical trial · Interventional
WISH, Feasibility of a Factorial Design
Women's Interventions for Sexual Health: WISH, Feasibility of a Factorial Design
NCT07023822CI-TRIAL-00110400completedN/AClinicalTrials.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)
The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Image | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sexual Desire Disorder | — | UNRESOLVED | — |
| Vulvovaginal Signs and Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyaluronic acid (HLA) Vaginal Moisturizer | Device | — | UNRESOLVED |
| Hypnotic Relaxation | Behavioral | — | UNRESOLVED |
| Polycarbophil Vaginal Moisturizer | Device | — | UNRESOLVED |
| Progressive Muscle Relaxation (PMR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis
- description
- Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks.
- interventionNames
- Device: Hyaluronic acid (HLA) Vaginal Moisturizer
- Behavioral: Hypnotic Relaxation
- type
- EXPERIMENTAL
- label
- Hyaluronic acid (HLA) Vaginal Moisturizer + PMR
- description
- Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks.
- interventionNames
- Device: Hyaluronic acid (HLA) Vaginal Moisturizer
- Behavioral: Progressive Muscle Relaxation (PMR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 female 2. Ability to read and write English 3. History of any stage of breast cancer 4. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study. 5. Able to engage in sexual activity including penetration or insertion into the vagina 6. Currently has a sexual partner. 7. Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?" 8. Responds "yes" to at least one of the following questions: * "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or * "Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?" Exclusion Criteria: 1. Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change. 2. An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report) 3. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed). 4. Previous participant in WISH Study 5. Currently receiving active treatment 6. Use of oral, transdermal or vaginal estrogen 7. Allergy or intolerance to Replens, Hyalo Gyn or any of their components.
References
Publications (0)
Data not yet available
No reference posted for this study.