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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Menopause

Postmenopausal Vaginal Atrophy

Treatments

Drug: estradiol, 25 mcg

Drug: estradiol, 10 mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01486979

2006-005957-31 (EudraCT Number)

VAG-1850

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

Female

Ages

60 to 70 years old

Volunteers

No Healthy Volunteers

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