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IRCT20191210045687N1 IRCT 2020-02-12 Shahid Beheshti University of Medical Sciences Evaluating the effectiveness of the traditional vaginal product on vulvovaginal atrophy Evaluating the effectiveness of vaginal cream (An Iranian Traditional Medicine product) on subjective symptoms of vulvovaginal atrophy in women with breast cancer 2020-02-15 anticipated 50 Complete https://irct.ir/trial/45128 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Vulvovaginal atrophy. Intervention group: Use Vaginal Cream (Traditional Iranian Medicine Product) Contains Chicken Oil and Honey Wax, One applicator every other night for 2 weeks followed by one applicator two nights a week for 2 weeks.. Yes - There is a plan to make this available What will be shared: Publication of results in the form of a Ph.D. thesis and an ISI paper When: After Ph.D. thesis defense To whom: Public Conditions: For research reasons Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: Confirmation of responsible person Comments:
public Maryam Radmanesh
No. 8, Shams Alley (across from Tavanir), Vali-e-Asr Ave.
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 m.radmanesh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Maryam Radmanesh
No. 8,Shams Alley (across from Tavanir), Vali-e-Asr Ave.
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 m.radmanesh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having a patient's consent to participate in the project Ability to fill out forms and questionnaires alone or with the help of a researcher 18 years or older Married Menopause History of breast cancer Hormonal treatment history Having subjective symptoms of vulvovaginal atrophy (itching, burning, dryness, dyspareunia) with a minimal sum score of 3 18 years no limit Female Having multiple sex partners Acute psychiatric illness and antidepressant use during the last month Other cancers at the same time as breast cancer Incomplete chemotherapy and radiotherapy Use of lubricant or vaginal moisturizer and other vaginal medications during the last month Not having a negative Pap smear over the last year N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Intervention group: Use Vaginal Cream (Traditional Iranian Medicine Product) Contains Chicken Oil and Honey Wax, One applicator every other night for 2 weeks followed by one applicator two nights a week for 2 weeks. Subjective Symptom Score of Vulvovaginal Atrophy Based on Vulvovaginal Subjective Symptom Score Form from 3 to 16. Timepoint: Evaluation of subjective symptoms of vulvovaginal atrophy at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion. Method of measurement: Vulvovaginal Subjective Symptom Score Form. Vulvovaginal Dryness Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4. Timepoint: Evaluation of vulvovaginal dryness at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion. Method of measurement: Vulvovaginal Subjective Symptom Score Form. Vulvovaginal Itching Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4. Timepoint: Evaluation of vulvovaginal Itching at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion. Method of measurement: Vulvovaginal Subjective Symptom Score Form. Vulvovaginal burning Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4. Timepoint: Evaluation of vulvovaginal burning at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion. Method of measurement: Vulvovaginal Subjective Symptom Score Form. Dyspareunia Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4. Timepoint: Evaluation of dyspareunia at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion. Method of measurement: Vulvovaginal Subjective Symptom Score Form. 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. Shahid Beheshti University of Medical Sciences Approved 2019-12-01 Ethics committee of Shahid Beheshti University of Medical Sciences 3th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)