Scandinavian Mirena Insertion Nulliparous Trial. | NCT00798980

Studies
Scandinavian Mirena Insertion Nulliparous Trial.

NCT00798980

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 22, 2015Estimated

Enrollment

224Actual

Phase

Not provided

Conditions

Nulliparous

Interventions

Mirena (BAY86-5028)

Countries

Sweden

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

Apr 2015

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

Feb 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Nov 2009Actual

First Submitted Date

Nov 26, 2008

First Submission Date that Met QC Criteria

Nov 26, 2008

First Posted Date

Nov 27, 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

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

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

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

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

Name	Type	Description	Arm Group Labels	Other Names
Mirena (BAY86-5028)	Drug	Nulliparous Women	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the insertion procedure of Mirena in nulliparous women		At the insertion time point

Secondary Outcomes

Measure	Description	Time Frame
Pain		At the insertion time point
Continuation rate		12-16 weeks post insertion
Bleeding Pattern

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nulliparous women Mirena insertion planned as contraceptive method

Exclusion Criteria:

Ongoing or suspected pregnancy;
Ongoing or recidivating genital infection;
Cervicitis;
Cervical dysplasia;
Malignancy in uterus or cervix;
Confirmed or suspected hormone sensitive neoplasia including breast cancer
Undiagnosed abnormal uterine bleeding;
Uterine anomaly including myoma if the cavity of the uterus is restricted;
Conditions that cause increased risk of infections;
Acute liver disease or liver tumour;
Allergy to the active substance or any component of the IUD

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Primary Care Clinic Patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21417562	Result	Marions L, Lovkvist L, Taube A, Johansson M, Dalvik H, Overlie I. Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):126-34. doi: 10.3109/13625187.2011.558222.

ID	Type	Description	Link
MA0710SE
SCAN 68/06
2006/0601120

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256