Effect of a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype) on subjective symptoms of vulvovaginal atrophy in women with breast cancer

Phase 3

Recruiting

• Conditions: vulvovaginal atrophy.; Postmenopausal atrophic vaginitis; N95.2

• Registration Number: IRCT20230923059496N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Married women
Being at the age of 18 to 50 years
With a history of estrogen receptor (ER) positive and/or progesterone receptor (PR) positive breast cancer
History of chemotherapy, radiotherapy or hormonal treatment due to breast cancer
At least 6 months have passed since menopause following chemotherapy, radiotherapy or hormonal treatment
The participant must be in the first two years of follow-up after the completion of adjuvant treatment and at the same time, at least 6 months have passed since the completion of chemotherapy
Complaining about subjective symptoms of vulvovaginal atrophy (itching, burning, dryness, dyspareunia) with a total score of at least 3
Having a negative pap smear in the last year
The patient's consent to participate in the project
The ability to fill out the forms and questionnaires alone or with the help of the researcher

Exclusion Criteria

Having an acute mental illness and using antidepressants in the last 4 weeks
Having a history of other cancers followed by chemotherapy and radiotherapy
Metastatic breast cancer
An increase in vaginal secretions and having a genitourinary infection

Study & Design

• Study Type: interventional
• Study Design: Not specified