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Effect of Alcea in treatment of vaginal atrophy.

Investigation of the effect of Alcea vaginal suppository on the treatment of vaginal atrophy in postmenopausal women.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180923041099N1
Enrollment
60
Registered
2019-02-24
Start date
2019-03-02
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Vaginal atrophy. Postmenopausal atrophic vaginitis

Interventions

Intervention 1: Intervention group: Alcea vaginal suppository(5%) every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of treatment is 8 weeks. All sta

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Married women, and have sexual activity; Age between 40-65 years; Complaint of vaginal dryness; Amenorrhea for at least 12 months, or laboratory confirmation of menopause(FSH>40); Amenorrhea after surgery and Bilateral Oophorectomy;

Exclusion criteria

Exclusion criteria: Endometrial cancer or breast cancer or suspicion of it; Vaginal bleeding with unknown causes; Vaginal infection; History of sensitivity to the Alcea; Chronic diseases; The history of consumption of hormonal products containing estrogen and progesterone in the last month; The history of vaginal use of stimulants that can cause chronic vaginal itching (scents, moisturizers, soaps) in the last month;

Design outcomes

Secondary

MeasureTime frame
Sexual satisfaction. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: Standard Questionnaire for Assessment of Female Sexual function (FSFI).

Primary

MeasureTime frame
Symptoms of vaginal atrophy. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: The most bothersome symptom of vaginal mucosa with Visual Analogue Scale.;Vaginal superficial cells. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: vaginal maturation index.;Vaginal PH. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: PH meter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlieh Kiani Talaei

Gorgan University of Medical Sciences

kianita941@mums.ac.ir+98 51 3869 5550

Outcome results

None listed

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