Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

Novo Nordisk A/S336 enrolled

Overview

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

336

Conditions

Menopause Postmenopausal Vaginal Atrophy

Interventions

estradiol, 10 mcgDRUG

Tablets, administered intravaginally twice weekly

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women whose last menstruation was at least two years prior to the time of screening * At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity * Generally healthy Exclusion Criteria: * Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

Locations (42)

Outcomes

Primary Outcomes

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies

The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.

Time frame: Week 52

Secondary Outcomes

Transvaginal Ultrasound: Endometrial Thickness

Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.

Time frame: Week 0, week 52

Data from ClinicalTrials.gov

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