vulvovaginal atrophy. Postmenopausal atrophic vaginitis
Conditions
Interventions
Intervention 1: Intervention group: Use a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype), One applicator every other night for 2 weeks followed by one appli
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Symptom Score of Vulvovaginal Atrophy Based on Vulvovaginal Subjective Symptom Score Form. Timepoint: Evaluation of subjective symptoms of vulvovaginal atrophy at baseline (before intervention), 2 and 4 weeks after the intervention beginning. Method of measurement: Vulvovaginal Subjective Symptom Score Form.;Vulvovaginal Dryness Score Based on Vulvovaginal Subjective Symptom Score Form. Timepoint: Evaluation of vulvovaginal dryness at baseline (before intervention), 2 and 4 weeks after the intervention beginning. Method of measurement: Vulvovaginal Subjective Symptom Score Form.;Vulvovaginal Itching Score Based on Vulvovaginal Subjective Symptom Score Form. Timepoint: Evaluation of vulvovaginal Itching at baseline (before intervention), 2 and 4 weeks after the intervention beginning. Method of measurement: Vulvovaginal Subjective Symptom Score Form.;Vulvovaginal burning Score Based on Vulvovaginal Subjective Symptom Score Form. Timepoint: Evaluation of vulvovaginal burning at baseline (before intervention), 2 and 4 weeks after the intervention beginning. Method of measurement: Vulvovaginal Subjective Symptom Score Form.;Dyspareunia Score Based on Vulvovaginal Subjective Symptom Score Form. Timepoint: Evaluation of dyspareunia at baseline (before intervention), 2 and 4 weeks after the intervention beginning. Method of measurement: Vulvovaginal Subjective Symptom Score Form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Female Sexual Function Index Score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Sexual desire score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Sexual arousal score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Vaginal lubrication score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Orgasm score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Sexual satisfaction score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Sexual pain score. Timepoint: At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion). Method of measurement: Female Sexual Function Index Questionnaire.;Satisfaction of treatment. Timepoint: After the Intervention completion. Method of measurement: Asking the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Ahmadi Basir
Shahid Beheshti University of Medical Sciences
Outcome results
None listed