Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

April 23, 2007

Last Updated Date

December 4, 2008

Start Date ^ICMJE

January 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Relief of vaginal symptoms [ Time Frame: over 12 months of treatment ]
Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels

Original Primary Outcome Measures ^ICMJE

Relief of vaginal symptoms over 12 months of treatment.
Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels.

Change History

Complete list of historical versions of study NCT00464971 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Vaginal health, vaginal cytology and urethral cytology

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

Official Title ^ICMJE

Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Brief Summary

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Atrophic Vaginitis

Intervention ^ICMJE

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

102

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Generally healthy
Postmenopausal
Hysterectomized or non-hysterectomized
Moderate or severe vaginal dryness and soreness
Successful completion of the study VAG/PD/009/USA

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
Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days

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

NCT00464971

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

VAG/PD/012/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