NCT01507454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,613

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

January 5, 2012

Last Update Submit

February 6, 2017

Conditions

MenopausePostmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (2)

  • Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'

  • Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms

Secondary Outcomes (1)

  • Adverse events

Study Arms (1)

Local treatment

Drug: estradiol, 25 mcg

Interventions

estradiol, 25 mcgDRUG

Vaginal tablets for 6-12 weeks according to product labelling

Local treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with atrophic vaginitis caused by estrogen deficiency prescribed with Vagifem® by their treating physician

You may qualify if:

  • Atrophic vaginitis due to estrogen deficiency
  • Post-menopausal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Location

Related Publications (1)

  • Stute P. Urogenitale Beschwerden und Östradioltherapie: Auswirkung einer vaginalen niedrig dosierten Östradioltherapie auf die Prävalenz und Intensität von urogenitalen Beschwerden. Gynäkologische Endokrinologie 2008; 6 (1): 48-52

    RESULT

Related Links

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 11, 2012

Study Start

April 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

DE(1)