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

This study has been completed.

Study NCT00431132 Information provided by Novo Nordisk

First Received on February 2, 2007. Last Updated on November 18, 2011 History of Changes

Results First Received: February 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Atrophic Vaginitis
Intervention:	Drug: estradiol, 10 mcg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
40 sites in Czech Republic, Denmark, Finland, France, Hungary, Norway, and Sweden

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Vagifem® 10 Mcg
STARTED	336
COMPLETED	292
NOT COMPLETED	44

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Vagifem® 10 Mcg
Number of Participants [units: participants]	336
Age [units: years] Mean ± Standard Deviation	59.5 ± 6.2
Gender [units: Subjects]
Female	336
Male	0
Race (NIH/OMB) [units: Subjects]
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	296
More than one race	0
Unknown or Not Reported	39
Body Mass Index (BMI) [units: kg/m^2] Mean ± Standard Deviation	24.6 ± 3.4

Outcome Measures

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1. Primary:

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies [ Time Frame: Week 52 ]

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2. Secondary:

Transvaginal Ultrasound: Endometrial Thickness [ Time Frame: Week 0, week 52 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Novo Nordisk acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a single-arm, 12-month, open label, multicentre trial; therefore there were no comparator results available.

Results Point of Contact:

Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com

No publications provided by Novo Nordisk

Publications automatically indexed to this study:

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.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00431132 History of Changes
Other Study ID Numbers:	VAG-1748, 2006-001629-24
Study First Received:	February 2, 2007
Results First Received:	February 7, 2011
Last Updated:	November 18, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Hungary: National Institute of Pharmacy; Finland: Finnish Medicines Agency; Czech Republic: State Institute for Drug Control; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency