Skip to content

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191210045687N1
Enrollment
50
Registered
2020-02-12
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal atrophy. Postmenopausal atrophic vaginitis

Interventions

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 we

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime 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 ContactMaryam Radmanesh

Shahid Beheshti University of Medical Sciences

m.radmanesh@sbmu.ac.ir+98 21 8877 3521

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026