Menopause, Postmenopausal Vaginal Atrophy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
Interventions
One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are able to use German language in speaking and writing * Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening * Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml * Maximum 5% superficial cells as assessed by evaluation of vaginal cytology * Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable) * Availability of a normal mammogram within one year prior to trial start * Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations
Exclusion criteria
* Known or suspected allergy to trial product or related products * Known, suspected or past history of breast cancer * Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer * Endometrial hyperplasia or endometrial polyps diagnosed during the screening period * Abnormal genital bleeding of unknown etiology * Previous estrogen and/ or progestin hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Average plasma concentration (C average) | — |
| Maximal concentration (Cmax) | — |
| Minimal concentration (Cmin) | — |
| Time of maximal concentration (tmax) | — |
| Incidence of adverse events | — |
Countries
Germany
Outcome results
None listed