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Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

Primary Purpose

Menopause, Postmenopausal Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
estradiol, 10 mcg
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal women whose last menstruation was at least two years prior to the time of screening
  • At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
  • Generally healthy

Exclusion Criteria:

  • Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vagifem® 10 mcg

Arm Description

One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks

Outcomes

Primary Outcome Measures

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.

Secondary Outcome Measures

Transvaginal Ultrasound: Endometrial Thickness
Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.

Full Information

First Posted
February 2, 2007
Last Updated
February 6, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00431132
Brief Title
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Official Title
A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Postmenopausal Vaginal Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vagifem® 10 mcg
Arm Type
Experimental
Arm Description
One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
Intervention Type
Drug
Intervention Name(s)
estradiol, 10 mcg
Intervention Description
Tablets, administered intravaginally twice weekly
Primary Outcome Measure Information:
Title
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Description
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Transvaginal Ultrasound: Endometrial Thickness
Description
Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.
Time Frame
Week 0, week 52

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal women whose last menstruation was at least two years prior to the time of screening At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity Generally healthy Exclusion Criteria: Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
603 00
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Prague 5
ZIP/Postal Code
150 00
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Prague
ZIP/Postal Code
128 00
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Virum
ZIP/Postal Code
2830
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33101
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Evry
ZIP/Postal Code
91000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NANTES Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nimes
ZIP/Postal Code
30006
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75017
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1034
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1088
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Drammen
ZIP/Postal Code
3015
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Hamar
ZIP/Postal Code
NO-2317
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Larvik
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0264
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Sandvika
ZIP/Postal Code
NO-1337
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Ski
ZIP/Postal Code
NO-1400
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
NO-4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
NO-4020
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Trondheim
ZIP/Postal Code
NO-7012
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
411 19
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
582 22
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
217 44
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Norrköping
ZIP/Postal Code
602 32
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
20859151
Citation
Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.
Results Reference
result
PubMed Identifier
18978105
Citation
Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3. Erratum In: Obstet Gynecol. 2008 Dec;112(6):1392.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

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