Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00108849

Enrollment

309

Registered

2005-04-20

Start date

2005-03-31

Completion date

2007-05-31

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 trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.

Interventions

DRUGestradiol, 10 mcg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Postmenopausal women whose last menstruation was at least two years previously

Design outcomes

Primary

Measure	Time frame
Clinical symptoms	after 12 months

Secondary

Measure	Time frame
Objective parameters (vaginal Maturation Index/Value and vaginal pH)	—
Hyperplasia rate	—

Countries

Canada, United States

Outcome results

None listed

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