Menopause, Postmenopausal Vaginal Atrophy
Conditions
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.
Interventions
Tablets, administered intravaginally twice weekly
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | 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
| Measure | Time frame | Description |
|---|---|---|
| Transvaginal Ultrasound: Endometrial Thickness | 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. |
Countries
Czechia, Denmark, Finland, France, Hungary, Norway, Sweden
Participant flow
Recruitment details
40 sites in Czech Republic, Denmark, Finland, France, Hungary, Norway, and Sweden
Participants by arm
| Arm | Count |
|---|---|
| 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 | 336 |
| Total | 336 |
Baseline characteristics
| Characteristic | Vagifem® 10 mcg |
|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 6.2 |
| Body Mass Index (BMI) | 24.6 kg/m^2 STANDARD_DEVIATION 3.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 39 Participants |
| Race (NIH/OMB) White | 296 Participants |
| Sex: Female, Male Female | 336 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 336 |
| serious Total, serious adverse events | 14 / 336 |
Outcome results
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.
Time frame: Week 52
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vagifem® 10 mcg | Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | Simple hyperplasia without atypia | 0 percentage of participants |
| Vagifem® 10 mcg | Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | Simple hyperplasia with atypia | 0 percentage of participants |
| Vagifem® 10 mcg | Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | Complex hyperplasia without atypia | 0 percentage of participants |
| Vagifem® 10 mcg | Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | Complex hyperplasia with atypia | 0 percentage of participants |
| Vagifem® 10 mcg | Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies | Carcinoma | 0 percentage of participants |
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.
Time frame: Week 0, week 52
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vagifem® 10 mcg | Transvaginal Ultrasound: Endometrial Thickness | Baseline | 2.04 mm | Standard Deviation 0.9 |
| Vagifem® 10 mcg | Transvaginal Ultrasound: Endometrial Thickness | Week 52 | 1.94 mm | Standard Deviation 0.9 |