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Treatment of genitourinary symptoms in menopausal women

Evaluation the effect of lactobacillus-containing vaginal cream on genitourinary symptoms of postmenopausal women

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241225064163N3
Enrollment
98
Registered
2025-05-27
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Urogenital syndrome includes symptoms such as burning, itching, vaginal dryness, and dyspareunia.. Candidiasis of other urogenital sites

Interventions

Intervention 1: Intervention group: The group receiving the Lactobacillus-containing cream.To prepare the cream, based on the weight of the Lyophilized Lactobacillus powder provided to us by ZistTakhm

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal women who have had at least 12 months since their last menstrual period Have at least one of the following symptoms: burning sensation in the urethra or vaginal burning, vaginal dryness, dyspareunia, and urinary frequency Normal urine test in the presence of urinary symptoms Having a normal mammogram

Exclusion criteria

Exclusion criteria: Presence of vaginal infection and discharge during examination Antibiotic use within one month of the study History of breast cancer or other estrogen-dependent cancers Presence of vaginal lesions other than scarring or erosion associated with atrophy History of thromboembolic events Use of injectable systemic estrogen within six months prior to the study Use of androgens or anabolic steroids within 6 months prior to the study Use of oral estrogen, progesterone, or DHEA-containing compounds within 8 weeks prior to the study Use of vaginal hormonal products (ring, cream, gel, or pill) or transdermal estrogen alone or in combination with progesterone within 8 weeks prior to the study History of endometrial cancer

Design outcomes

Primary

MeasureTime frame
Urogenital syndrome includes symptoms such as burning, itching, vaginal dryness, and dyspareunia. Timepoint: 4 week. Method of measurement: Symptoms related to vulvovaginal and urogenital atrophy are assessed using the standard Menopause Rating Scale (MRS) questionnaire.;Menopause symptom severity grading. Timepoint: 1 day. Method of measurement: Menopause symptom severity scale questionnaire.;Vaginal health (elasticity, discharge, mucosal condition, moisture). Timepoint: 1 day. Method of measurement: To assess vaginal health objectively, the Vaginal Health Index (VHI) will be used, which includes evaluation of five parameters: elasticity, discharge, vaginal pH, mucosal condition, and moisture. This assessment will be conducted at both the beginning and the end of the study.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsieh Maleki

Mashhad University of Medical Sciences

malekia@mums.ac.ir+98 51 3802 2608

Outcome results

None listed

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