Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT03628092
Eligibility Criteria:
Inclusion Criteria:
* Women with a history of early breast cancer \>18 years of age
* At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.
* Three groups of patients will qualify:
* Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \>6 months
* Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor
* Postmenopausal women on tamoxifen or an aromatase inhibitor
* Willingness to give written informed consent and willingness to comply with the study
* Up to date pap test / HPV (human papillomavirus) testing
Exclusion Criteria:
* Medical contraindication to the use of fractional ablative CO2 laser
* Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment
* Use of vaginal lubricants or moisturisers 14 days prior to the study treatment
* Active or recent genitourinary infections (\<30 days)
* Genital prolapse (grade III)
* Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts)
* Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03628092
Study Brief:
Protocol Section:
NCT03628092