Menopause, Postmenopausal Vaginal Atrophy
Conditions
Brief summary
This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.
Interventions
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Generally healthy * Postmenopausal * Hysterectomized or non-hysterectomized * Moderate or severe vaginal dryness and soreness * Successful completion of the study VAG/PD/009/USA
Exclusion criteria
* Known, suspected, or past history of breast cancer * Known, suspected, or past history of hormone-dependent tumor * Genital bleeding of unknown etiology * Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use * Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA * Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief of vaginal symptoms | over 12 months of treatment |
| Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal health, vaginal cytology and urethral cytology | — |
Outcome results
None listed