manufacturing Of estradiol vaginal tablets.

Comparison of vaginal tablets produced at the Faculty of Pharmacy and Vagifem on vaginal dryness in patients with atrophic vaginitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201309298022N2

Enrollment

Registered

2013-12-04

Start date

2013-11-06

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

Atrophic vaginitis. Senile (atrophic) vaginitis

Interventions

Intervention 1: Control group: vagifem vaginal tablets (25 micrograms 17 beta-estradiol) for 12 weeks, The first two weeks, one tablet a day, two pills per week for ten weeks. Intervention 2: Interven

Treatment - Drugs

Control group: vagifem vaginal tablets (25 micrograms 17 beta-estradiol) for 12 weeks, The first two weeks, one tablet a day, two pills per week for ten weeks.

Intervention group: Formulated 17 beta-estradiol vaginal tablets (25 micrograms) in the Faculty of Pharmacy, Kermanshah, for 12 weeks. The first two weeks, one tablet a day, two pills per week for ten

Eligibility

Sex/Gender

Female

Age

40 Years to 90 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: Female; having atrophic vaginitis; approved by gynecologist exclusion sriteria: cervicitis; cervical dysplasia; Bacterial Vaginitis; visible cervical lesions; patients treated with oral estrogen.

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
Headaches. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction on VAS.;Nausea. Timepoint: before and three months after intervention. Method of measurement: Satisfaction on VAS.;Vaginal bleeding. Timepoint: before and three months after intervention. Method of measurement: Satisfaction on VAS.	—

Primary

Measure	Time frame
Dysparenuia. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.;Vaginal discharge. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.;Vaginal dryness. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.;Vaginal irritation. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.	—

Measure

Time frame

Dysparenuia. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.;Vaginal discharge. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.;Vaginal dryness. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.;Vaginal irritation. Timepoint: Before and three months after intervention. Method of measurement: Satisfaction questionnaire based on VAS.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Katayoun Derakhshandeh

Faculty of Pharmacy, Kermanshah University of Medical Sciences

kderakhshandeh@kums.ac.ir+98 83 1427 6508

Outcome results

None listed

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