Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01507454

Enrollment

1613

Registered

2012-01-11

Start date

2006-04-30

Completion date

2006-11-30

Last updated

2017-02-08

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

Conditions

Menopause, Postmenopausal Vaginal Atrophy

Brief summary

This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.

Interventions

DRUGestradiol, 25 mcg

Vaginal tablets for 6-12 weeks according to product labelling

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Atrophic vaginitis due to estrogen deficiency * Post-menopausal

Design outcomes

Primary

Measure	Time frame
Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'	—
Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms	—

Secondary

Measure	Time frame
Adverse events	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026