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The Effect of Cumin Vaginal Cream on Vaginal Atrophy, Sexual Function Index and Sexual Distress in Postmenopausal Women, Gonanbad –2022

Phase 3
Conditions
Vaginal atrophy.
Postmenopausal atrophic vaginitis
N95.2
Registration Number
IRCT20220926056043N1
Lead Sponsor
Gonabad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
84
Inclusion Criteria

Age between 45 and 65 years
1 to 2 years have passed since menopause
Having at least a degree with reading and writing literacy
Having informed consent to participate in the research
Married and monogamous
No history of pelvic surgery (according to the participant's statement)
Non-use of drugs and alcohol in the woman and her husband (according to the participant's statement)
Not taking estrogenic drugs
Absence of vaginal bleeding
No history of radiation therapy or chemotherapy of the pelvis or the whole body
No cancer
No history of infertility (according to the participant's statement)
Absence of spouse suffering from premature ejaculation or impotence (according to the participant's statement)
Absence of vaginal infections (based on the participants' statements and questions about the clinical symptoms of vaginitis)
Not suffering from psychological disorders such as: psychosis, schizophrenia, delusions, etc. (according to the participant himself)
Having at least 2 symptoms from the descriptive evaluation table of the vaginal mucosa (color, roughness, petechiae, elasticity, dryness)
Obtaining a score of 23 or less according to the Sexual Performance Index (FSFI) questionnaire
Not having diabetes (according to the participant's statement)

Exclusion Criteria

Allergy to cumin vaginal cream
Taking any medication affecting sexual performance during the study
Starting to take hormonal drugs during the study
Experiencing unfortunate or stressful events in a woman or her husband
Dissatisfaction to continue cooperation in research
Absence of diseases in women or their spouses that affect sexual performance (such as premature ejaculation, cardiovascular, mental, thyroid and cancers)
Getting stressed (such as divorce, infidelity of a spouse, death of loved ones in the last year, serious illnesses or imprisonment)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vaginal atrophy. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Descriptive assessment of vaginal mucosa.;Sexual function. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Female Sexual Function Index.;Women's sexual distress. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Female Sexual Distress Scal.;Vaginal atrophy daily effects. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Vaginal atrophy daily effects questionnaire.
Secondary Outcome Measures
NameTimeMethod
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