Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Menopause

Postmenopausal Vaginal Atrophy

Treatments

Drug: estradiol, 25 mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01085877

U1111-1113-4908 (Other Identifier)

2009-017034-50 (EudraCT Number)

VAG-3821

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.

Enrollment

70 patients

Sex

Female

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who are able to use the German language, spoken and written
Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
Availability of a normal mammogram within 1 year prior to trial start
Good general health
No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician

Exclusion criteria

Known or suspected allergy to estradiol or related products
Known, suspected or past history of breast cancer
Abnormal genital bleeding
Previous oestrogen and/or progestin hormone replacement therapy
Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
Hot flushes which require systemic hormone replacement treatment
Known insulin dependent or non-insulin dependent diabetes mellitus
Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
Active arterial thrombosis or a documented history of this condition
Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
Known HIV infection based on laboratory result
Porphyria
Body Mass Index (BMI) above 30.0 kg/m2
Cervical smear presenting PAP of more than class II
Known or suspected vaginal infection requiring further treatment
Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration