Study to Evaluate Divigel for the Treatment of Postmenoup... | NCT00727129

Studies
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

NCT00727129

Sponsor

Upsher-Smith Laboratories

Status

Completed

Last Update Posted

Sep 26, 2008Estimated

Enrollment

495Actual

Phase

Phase 3

Conditions

Postmenopausal Symptoms

Interventions

Divigel

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

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Jul 29, 2008

First Submission Date that Met QC Criteria

Jul 31, 2008

First Posted Date

Aug 1, 2008Estimated

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

Sep 25, 2008

Last Update Posted Date

Sep 26, 2008Estimated

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

495Actual

Name	Type	Description	Arm Group Labels	Other Names
Divigel	Drug

Measure	Description	Time Frame
Daily frequency and severity of moderate to severe vasomotor symptoms

Measure	Description	Time Frame
vulvar and vaginal atrophy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women
Have moderate to severe hot flashes
Normal Pap Smear

Exclusion Criteria:

Abnormal mammogram
Abnormal clinical breast exam
BMI >35

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Hedrick RE. Low-dose estradiol gel 0.1% for the treatment of vasomotor symptoms associated with menopause. Expert Review of Obstetrics & Gynecology, 3(2): Pages 155-162, Mar 2008.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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