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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-05-31

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.

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Detailed Description

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Conditions

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Menopause Postmenopausal Vaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose

Group Type EXPERIMENTAL

estradiol, 10 mcg

Intervention Type DRUG

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

High dose

Group Type ACTIVE_COMPARATOR

estradiol, 25 mcg

Intervention Type DRUG

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

Interventions

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estradiol, 10 mcg

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

Intervention Type DRUG

estradiol, 25 mcg

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

Intervention Type DRUG

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No