Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 23, 2007

Last Updated Date

December 1, 2008

Start Date ^ICMJE

August 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Relief of vaginal symptoms [ Time Frame: following 12 weeks of treatment. ]

Original Primary Outcome Measures ^ICMJE

Relief of vaginal symptoms following 12 weeks of treatment.

Change History

Complete list of historical versions of study NCT00465192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events
Hematology and chemisty tests, and endometrial biopsy
Vaginal and urethral cytology, and grading of vaginal health

Original Secondary Outcome Measures ^ICMJE

Adverse Events, hematology and chemistry tests, and endometrial biopsy.
Vaginal and urethral cytology, and grading of vaginal health.

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Brief Summary

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Atrophic Vaginitis

Intervention ^ICMJE

Drug: 17-Beta Estradiol, 10 micrograms
Drug: 17-Beta Estradiol, 25 micrograms

Study Arms / Comparison Groups

Publications *

Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):67-76.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

230

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Generally healthy
Postmenopausal
Hysterectomized or non-hysterectomized
Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

Known, suspected, or past history of breast cancer
Known, suspected, or past history of hormone-dependent tumor
Genital bleeding of unknown etiology
Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
Vaginal infection
Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
History of treatment with diethylstilbestrol

Gender

Female

Ages

45 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00465192

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

VAG/PD/009/USA

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jan Öhrström, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2008

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