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

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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 Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Menopause
Postmenopausal Vaginal Atrophy
Intervention Drug: estradiol, 10 mcg
Enrollment 336
Recruitment Details 40 sites in Czech Republic, Denmark, Finland, France, Hungary, Norway, and Sweden
Pre-assignment Details  
Arm/Group Title Vagifem® 10 mcg
Hide Arm/Group 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
Period Title: Overall Study
Started 336
Completed 292
Not Completed 44
Arm/Group Title Vagifem® 10 mcg
Hide Arm/Group 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
Overall Number of Baseline Participants 336
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 336 participants
59.5  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants
Female
336
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
296
  88.1%
More than one race
0
   0.0%
Unknown or Not Reported
39
  11.6%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 336 participants
24.6  (3.4)
1.Primary Outcome
Title Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.
Arm/Group Title Vagifem® 10 mcg
Hide Arm/Group 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
Overall Number of Participants Analyzed 336
Measure Type: Number
Unit of Measure: percentage of participants
Simple hyperplasia without atypia 0
Simple hyperplasia with atypia 0
Complex hyperplasia without atypia 0
Complex hyperplasia with atypia 0
Carcinoma 0
2.Secondary Outcome
Title Transvaginal Ultrasound: Endometrial Thickness
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.
Arm/Group Title Vagifem® 10 mcg
Hide Arm/Group 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
Overall Number of Participants Analyzed 334
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 2.04  (0.9)
Week 52 1.94  (0.9)
Time Frame Adverse events were collected over a time frame of 12 months.
Adverse Event Reporting Description Adverse events were collected from the first trial related activity after the subject has signed the informed consent to the end-of-trial. The safety population includes subjects who received 52 weeks of treatment with Vagifem 10 mcg of trial drug.
 
Arm/Group Title Vagifem® 10 mcg
Hide Arm/Group 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
All-Cause Mortality
Vagifem® 10 mcg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vagifem® 10 mcg
Affected / at Risk (%) # Events
Total   14/336 (4.17%)    
Cardiac disorders   
Myocardial infarction  1  1/336 (0.30%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/336 (0.30%)  1
Melaena  1  1/336 (0.30%)  1
Hepatobiliary disorders   
Cholelithiasis  1  1/336 (0.30%)  1
Injury, poisoning and procedural complications   
Forearm fracture  1  1/336 (0.30%)  1
Post procedural haematoma  1  1/336 (0.30%)  1
Radius fracture  1  2/336 (0.60%)  2
Musculoskeletal and connective tissue disorders   
Spinal column stenosis  1  1/336 (0.30%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon adenoma  1  1/336 (0.30%)  1
Leukaemia recurrent  1  1/336 (0.30%)  1
Meningioma  1  1/336 (0.30%)  1
Metastases to central nervous system  1  1/336 (0.30%)  1
Nervous system disorders   
Thrombotic cerebral infarction  1  1/336 (0.30%)  1
Renal and urinary disorders   
Urinary incontinence  1  1/336 (0.30%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vagifem® 10 mcg
Affected / at Risk (%) # Events
Total   17/336 (5.06%)    
Infections and infestations   
Nasopharyngitis  1  17/336 (5.06%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
This was a single-arm, 12-month, open label, multicentre trial; therefore there were no comparator results available.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Novo Nordisk acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00431132     History of Changes
Other Study ID Numbers: VAG-1748
2006-001629-24 ( EudraCT Number )
First Submitted: February 2, 2007
First Posted: February 5, 2007
Results First Submitted: February 7, 2011
Results First Posted: April 7, 2011
Last Update Posted: March 15, 2017