Trial Outcomes & Findings for Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis (NCT NCT00431132)
NCT ID: NCT00431132
Last Updated: 2017-03-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
336 participants
Primary outcome timeframe
Week 52
Results posted on
2017-03-15
Participant Flow
40 sites in Czech Republic, Denmark, Finland, France, Hungary, Norway, and Sweden
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
336
|
|
Overall Study
COMPLETED
|
292
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Baseline characteristics by cohort
| Measure |
Vagifem® 10 mcg
n=336 Participants
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
|
|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
296 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.6 kg/m^2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: 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.
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.
Outcome measures
| Measure |
Vagifem® 10 mcg
n=336 Participants
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
|
|---|---|
|
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Simple hyperplasia without atypia
|
0 percentage of participants
|
|
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Simple hyperplasia with atypia
|
0 percentage of participants
|
|
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Complex hyperplasia without atypia
|
0 percentage of participants
|
|
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Complex hyperplasia with atypia
|
0 percentage of participants
|
|
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Carcinoma
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: 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.
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.
Outcome measures
| Measure |
Vagifem® 10 mcg
n=334 Participants
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
|
|---|---|
|
Transvaginal Ultrasound: Endometrial Thickness
Baseline
|
2.04 mm
Standard Deviation 0.9
|
|
Transvaginal Ultrasound: Endometrial Thickness
Week 52
|
1.94 mm
Standard Deviation 0.9
|
Adverse Events
Vagifem® 10 mcg
Serious events: 14 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vagifem® 10 mcg
n=336 participants at risk
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
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Gastrointestinal disorders
Melaena
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.60%
2/336 • Number of events 2 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.30%
1/336 • Number of events 1 • Adverse events were collected over a time frame of 12 months.
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.
|
Other adverse events
| Measure |
Vagifem® 10 mcg
n=336 participants at risk
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
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.1%
17/336 • Number of events 18 • Adverse events were collected over a time frame of 12 months.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER