Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001629-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagifem® 10 mcg | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estradiol, 10 mcg | Drug | Tablets, administered intravaginally twice weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Brno | 602 00 | Czechia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20859151 | Result | 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. | |
| 18978105 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
40 sites in Czech Republic, Denmark, Finland, France, Hungary, Norway, and Sweden
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brno |
| 603 00 |
| Czechia |
| Novo Nordisk Investigational Site | Olomouc | 779 00 | Czechia |
| Novo Nordisk Investigational Site | Prague | 128 00 | Czechia |
| Novo Nordisk Investigational Site | Prague | 150 00 | Czechia |
| Novo Nordisk Investigational Site | Århus N | 8200 | Denmark |
| Novo Nordisk Investigational Site | Glostrup Municipality | 2600 | Denmark |
| Novo Nordisk Investigational Site | Herlev | 2730 | Denmark |
| Novo Nordisk Investigational Site | Hillerød | 3400 | Denmark |
| Novo Nordisk Investigational Site | Roskilde | 4000 | Denmark |
| Novo Nordisk Investigational Site | Virum | 2830 | Denmark |
| Novo Nordisk Investigational Site | Espoo | 02100 | Finland |
| Novo Nordisk Investigational Site | Kuopio | 70100 | Finland |
| Novo Nordisk Investigational Site | Oulu | 90100 | Finland |
| Novo Nordisk Investigational Site | Tampere | 33101 | Finland |
| Novo Nordisk Investigational Site | Turku | 20100 | Finland |
| Novo Nordisk Investigational Site | Évry | 91000 | France |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Nîmes | 30006 | France |
| Novo Nordisk Investigational Site | Paris | 75005 | France |
| Novo Nordisk Investigational Site | Paris | 75015 | France |
| Novo Nordisk Investigational Site | Paris | 75017 | France |
| Novo Nordisk Investigational Site | Budapest | H-1034 | Hungary |
| Novo Nordisk Investigational Site | Budapest | H-1088 | Hungary |
| Novo Nordisk Investigational Site | Budapest | H-1096 | Hungary |
| Novo Nordisk Investigational Site | Pécs | H-7624 | Hungary |
| Novo Nordisk Investigational Site | Szeged | H-6725 | Hungary |
| Novo Nordisk Investigational Site | Drammen | 3015 | Norway |
| Novo Nordisk Investigational Site | Hamar | NO-2317 | Norway |
| Novo Nordisk Investigational Site | Larvik | Norway |
| Novo Nordisk Investigational Site | Oslo | 0264 | Norway |
| Novo Nordisk Investigational Site | Sandvika | NO-1337 | Norway |
| Novo Nordisk Investigational Site | Ski | NO-1400 | Norway |
| Novo Nordisk Investigational Site | Stavanger | NO-4011 | Norway |
| Novo Nordisk Investigational Site | Stavanger | NO-4020 | Norway |
| Novo Nordisk Investigational Site | Trondheim | NO-7012 | Norway |
| Novo Nordisk Investigational Site | Gothenburg | 411 19 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 416 85 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 582 22 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 217 44 | Sweden |
| Novo Nordisk Investigational Site | Norrköping | 602 32 | Sweden |
| Novo Nordisk Investigational Site | Uppsala | 751 85 | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | percentage of participants | Week 52 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | mm | Week 0, week 52 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 14 | 336 | 17 | 336 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
This was a single-arm, 12-month, open label, multicentre trial; therefore there were no comparator results available.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Complex hyperplasia with atypia |
|
| Carcinoma |
|
|