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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00431132
First received: February 2, 2007
Last updated: March 19, 2012
Last verified: March 2012
History of Changes

February 2, 2007
March 19, 2012
January 2007
November 2008   (final data collection date for primary outcome measure)
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
Endometrial hyperplasia rate based on histological assessment of endometrial biopsies taken at the end of 12 months of treatment with Vagifem Low dose compared to baseline
Complete list of historical versions of study NCT00431132 on ClinicalTrials.gov Archive Site
Transvaginal Ultrasound: Endometrial Thickness [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
Not Provided
 
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Menopause
  • Postmenopausal Vaginal Atrophy
Drug: estradiol, 10 mcg
Tablets, administered intravaginally twice weekly
Experimental: Vagifem® 10 mcg
One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
Intervention: Drug: estradiol, 10 mcg
Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Female
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Denmark,   Finland,   France,   Hungary,   Norway,   Sweden
 
NCT00431132
VAG-1748, 2006-001629-24
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Michaela Eugster-Hausmann, MD Novo Nordisk FemCare AG
Novo Nordisk
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP