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Vaginal gel Chamomile and Conjugated Estrogen in the treatment of vaginal atrophy

Comparison the effect of Chamomile vaginal gel with Conjugated Estrogen in the treatment of vaginal atrophy in postmenopausal women

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171218037943N1
Enrollment
96
Registered
2018-01-21
Start date
2018-01-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Vaginal Atrophy in Postmenopausal Women. Postmenopausal atrophic vaginitis

Interventions

Intervention 1: First intervention group: Vaginal Cream, Conjugated Estrogen ./625 Mg, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week), Aburaihan Pharmac
Treatment - Drugs
Placebo
First intervention group: Vaginal Cream, Conjugated Estrogen ./625 Mg, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week), Aburaihan Pharmacy Company
Two intervention group:chamomile vaginal gel 5%, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week)
Control group: placebo vaginal gel, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week)

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: People who have had at least one year of their last menstruation or have a hormonal test with an average fsh> 40 international units There are symptoms of vaginal atrophy The age range is 45-65 years Have sex and monogamy

Exclusion criteria

Exclusion criteria: Vaginal infection needs treatment Genital abnormalities Hormone therapy or use of sexual hormones during the 8 weeks prior to the study Using vaginal medicines or any lubricant at least 15 days before the study Tobacco use (alcohol, cigarette and hookah) Breast diseases with unknown cause Uterine bleeding or spotting with unspecified cause Excessive consumption of phytoestrogens such as soy, red clover, fenugreek over the past month BMI more than 30 Cholestatic Diseases of the Liver Severe kidney failure Acute Thrombophlebitis High blood pressure

Design outcomes

Primary

MeasureTime frame
Vaginal atrophy. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Cooperman Index Questionnaire.;Percentage of vaginal cell maturation. Timepoint: Before intervention, after intervention. Method of measurement: Vaginal smear.;Vaginal acidity. Timepoint: Before intervention, after intervention. Method of measurement: PH gauge.

Secondary

MeasureTime frame
Painful intercourse. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Self-assessment scale is 4 degrees.;Menopause symptoms. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Cooperman Index Questionnaire.;Severity of menopause symptoms. Timepoint: At the beginning of the study, 14, 42 and 84 days after Intervention. Method of measurement: Menopause Rating Scale.;Sexual performance. Timepoint: Before and after the intervention. Method of measurement: Female Sexual Function Index (FSFI).;Sexual satisfaction. Timepoint: Before and after the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Bosak

Ahvaz University of Medical Sciences

zahrabosak@gmail.com+98 61 3336 1984

Outcome results

None listed

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