Mirena Efficiency and Tolerability During the First Year... | NCT00696202

Studies
Mirena Efficiency and Tolerability During the First Year of Use

NCT00696202

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 31, 2014Estimated

Enrollment

199Actual

Phase

Phase 4

Conditions

Medicated Intrauterine Devices
Contraception

Interventions

Mirena (BAY86-5028)

Countries

France

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

ID	Type	Description	Link
307702

Status Module

Record Verification Date

Dec 2014

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

Sep 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 11, 2008

First Posted Date

Jun 12, 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

Dec 30, 2014

Last Update Posted Date

Dec 31, 2014Estimated

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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Mirena (BAY86-5028)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirena (BAY86-5028)	Drug	Intrauterine levonorgestrel containing device (market product)	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena		within 12 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
General safety assessment		within 12 months after randomization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

Exclusion Criteria:

Standard exclusion criteria for use of intrauterine hormone devices

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D016912	Levonorgestrel

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided