HR-QoL and Sexuality in Mirena Inserted Contraception Users | NCT00498784

Studies
HR-QoL and Sexuality in Mirena Inserted Contraception Users

NCT00498784

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 23, 2013Estimated

Enrollment

141Actual

Phase

Phase 4

Conditions

Contraception

Interventions

Mirena

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
2005-002955-42	EudraCT Number
309663	Other Identifier	Company internal

Status Module

Record Verification Date

Jan 2013

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

Nov 2005

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jul 9, 2007

First Submission Date that Met QC Criteria

Jul 9, 2007

First Posted Date

Jul 10, 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

Jan 21, 2013

Last Update Posted Date

Jan 23, 2013Estimated

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

The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

141Actual

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Mirena

Name	Type	Description	Arm Group Labels	Other Names
Mirena	Drug	Mirena 52mg during 1 year	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health-related QoL score		1 year

Secondary Outcomes

Measure	Description	Time Frame
Sexuality Index, treatment satisfaction, usual safety outcomes		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy woman willing to, or having to switch from her OC to another contraceptive method

Exclusion Criteria:

- Any contraindication to Mirena insertion/use

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Bordeaux	Gironde	33076	France

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