Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

Study Overview
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Brief Summary
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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.

Official Title
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A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis

Conditions
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Menopause, Postmenopausal Vaginal Atrophy

Intervention / Treatment
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* Drug: estradiol, 10 mcg
* Drug: estradiol, 25 mcg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: estradiol, 10 mcg<br>* 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<br>|
| Active Comparator: High dose<br> | Drug: estradiol, 25 mcg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average plasma concentration (C average) |  |  | 
| Maximal concentration (Cmax) |  |  | 
| Minimal concentration (Cmin) |  |  | 
| Time of maximal concentration (tmax) |  |  | 
| Incidence of adverse events |  |  |