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Non Hormonal Treatment of Vaginal Atrophy

The effect of vitamin D and E vaginal suppository on vaginal atrophy in women with breast cancer who taking tamoxifen

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016100229683N2
Enrollment
150
Registered
2016-10-31
Start date
2016-10-05
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. Diseases of the genitourinary system (N00-N99)

Interventions

Intervention 1: Group 1, will be received an intervention that included vaginal suppositories vitamin D (1000 IU Vitamin D in addition to 2 gr the base material), once a day for 2 months. Intervention
Treatment - Drugs
Group 1, will be received an intervention that included vaginal suppositories vitamin D (1000 IU Vitamin D in addition to 2 gr the base material), once a day for 2 months
Group 2, will be received an intervention that included vaginal suppositories vitamin E, (1 mg vitamin E in addition to 2 gr the base material), once a day for 2 months
Control group, the women in control group will be received placebo vaginal suppositories containing 2 gr base material, (Suppocire AS2), once a day for 2 months

Sponsors

Vice chancellor for research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
17 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: being married; having stage 1 and 2 breast cancer based on surgery staging; use of tamoxifen; non-use of chemotherapy or radiation during this study; aged under 50 years; with at least one of the symptoms of the self-assessment urogenital atrophy questionnaire; normal Pap smear within the last 3 years; no proven cancer in other organs of the body based on the results recorded in patient records; having sexual activity.Exclusion criteria: vaginal infection (confirmed by Microbiological analysis); abnormal Pap smear; estrogen therapy during the past 8 weeks; unexplained vaginal bleeding; recurrent disease based on the diagnostic results recorded in patient records; smoking cigarette.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Vaginal ph. Timepoint: Before intervention, Two weeks after the intervention, Four weeks after intervention, eight weeks after intervention. Method of measurement: PH indicator strip.

Secondary

MeasureTime frame
Vaginal cell Maturation. Timepoint: Before intervention, eight weeks after intervention. Method of measurement: Vaginal Maturation Index.;Symptoms of vaginal atrophy. Timepoint: Before intervention, Two weeks after the intervention, Four weeks after intervention, eight weeks after intervention. Method of measurement: Self-assessment urogenital atrophy questionnaire (UAQ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Roksana Janghorban

School of Nursing and Midwifery, Shiraz University of Medical Sciences

janghorban@sums.ac.ir+98 71 3647 4254

Outcome results

None listed

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