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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00431132
Recruitment Status : Completed
First Posted : February 5, 2007
Results First Posted : April 7, 2011
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Postmenopausal Vaginal Atrophy Drug: estradiol, 10 mcg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vagifem® 10 mcg
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
 Drug: estradiol, 10 mcg
Tablets, administered intravaginally twice weekly


Outcome Measures
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Primary Outcome Measures :
  1. Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies [ Time Frame: Week 52 ]
    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 :
  1. Transvaginal Ultrasound: Endometrial Thickness [ Time Frame: Week 0, week 52 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431132


Locations
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Czech Republic
Novo Nordisk Investigational Site
Brno, Czech Republic, 602 00
Novo Nordisk Investigational Site
Brno, Czech Republic, 603 00
Novo Nordisk Investigational Site
Olomouc, Czech Republic, 779 00
Novo Nordisk Investigational Site
Prague 5, Czech Republic, 150 00
Novo Nordisk Investigational Site
Prague, Czech Republic, 128 00
Denmark
Novo Nordisk Investigational Site
Glostrup, Denmark, 2600
Novo Nordisk Investigational Site
Herlev, Denmark, 2730
Novo Nordisk Investigational Site
Hillerød, Denmark, 3400
Novo Nordisk Investigational Site
Roskilde, Denmark, 4000
Novo Nordisk Investigational Site
Virum, Denmark, 2830
Novo Nordisk Investigational Site
Århus N, Denmark, 8200
Finland
Novo Nordisk Investigational Site
Espoo, Finland, 02100
Novo Nordisk Investigational Site
Kuopio, Finland, 70100
Novo Nordisk Investigational Site
Oulu, Finland, 90100
Novo Nordisk Investigational Site
Tampere, Finland, 33101
Novo Nordisk Investigational Site
Turku, Finland, 20100
France
Novo Nordisk Investigational Site
Evry, France, 91000
Novo Nordisk Investigational Site
NANTES Cedex 1, France, 44093
Novo Nordisk Investigational Site
Nimes, France, 30006
Novo Nordisk Investigational Site
Paris, France, 75005
Novo Nordisk Investigational Site
Paris, France, 75015
Novo Nordisk Investigational Site
Paris, France, 75017
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, H-1034
Novo Nordisk Investigational Site
Budapest, Hungary, H-1088
Novo Nordisk Investigational Site
Budapest, Hungary, H-1096
Novo Nordisk Investigational Site
Pecs, Hungary, H-7624
Novo Nordisk Investigational Site
Szeged, Hungary, H-6725
Norway
Novo Nordisk Investigational Site
Drammen, Norway, 3015
Novo Nordisk Investigational Site
Hamar, Norway, NO-2317
Novo Nordisk Investigational Site
Larvik, Norway
Novo Nordisk Investigational Site
Oslo, Norway, 0264
Novo Nordisk Investigational Site
Sandvika, Norway, NO-1337
Novo Nordisk Investigational Site
Ski, Norway, NO-1400
Novo Nordisk Investigational Site
Stavanger, Norway, NO-4011
Novo Nordisk Investigational Site
Stavanger, Norway, NO-4020
Novo Nordisk Investigational Site
Trondheim, Norway, NO-7012
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 411 19
Novo Nordisk Investigational Site
Göteborg, Sweden, 416 85
Novo Nordisk Investigational Site
Linköping, Sweden, 582 22
Novo Nordisk Investigational Site
Malmö, Sweden, 217 44
Novo Nordisk Investigational Site
Norrköping, Sweden, 602 32
Novo Nordisk Investigational Site
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00431132    
Other Study ID Numbers: VAG-1748
2006-001629-24 ( EudraCT Number )
First Posted: February 5, 2007    Key Record Dates
Results First Posted: April 7, 2011
Last Update Posted: March 15, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Vaginitis
Atrophic Vaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginal Diseases
 Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs