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

NCT ID: NCT01085877

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-05-31

Brief Summary

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.

Conditions

Menopause; Postmenopausal Vaginal Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trial part 1

Group Type: ACTIVE_COMPARATOR

estradiol, 25 mcg

Intervention Type: DRUG

Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)

Trial part 2

Group Type: EXPERIMENTAL

estradiol, 25 mcg

Intervention Type: DRUG

Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)

Interventions

estradiol, 25 mcg

Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)

Intervention Type: DRUG

estradiol, 25 mcg

Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Mainz, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1113-4908

Identifier Type: OTHER

Identifier Source: secondary_id

2009-017034-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAG-3821

Identifier Type: -

Identifier Source: org_study_id