Efficacy and Safety of 17-Beta Estradiol in Treatment of... | NCT00465192

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

NCT00465192

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

230Estimated

Phase

Phase 3

Conditions

Menopause
Postmenopausal Vaginal Atrophy

Interventions

estradiol, 10 mcg
estradiol, 25 mcg
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 1994Actual

Primary Completion Date

Nov 30, 1995Actual

Completion Date

Nov 30, 1995Actual

First Submitted Date

Apr 23, 2007

First Submission Date that Met QC Criteria

Apr 23, 2007

First Posted Date

Apr 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief of vaginal symptoms		following 12 weeks of treatment.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18165394	Derived	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. doi: 10.1097/01.AOG.0000296714.12226.0f.

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Name	Type	Description	Arm Group Labels	Other Names
estradiol, 10 mcg	Drug
estradiol, 25 mcg	Drug
placebo	Drug