Menopause, Postmenopausal Vaginal Atrophy
Conditions
Brief summary
This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
Interventions
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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
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 * Vaginal infection * Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study * Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study * History of treatment with diethylstilbestrol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief of vaginal symptoms | following 12 weeks of treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| Hematology and chemisty tests, and endometrial biopsy | — |
| Vaginal and urethral cytology, and grading of vaginal health | — |
Outcome results
None listed