FR01 and FR20 IUS (Intrauterine System) Wearing Study | NCT01595022

Studies
FR01 and FR20 IUS (Intrauterine System) Wearing Study

NCT01595022

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 3, 2015Estimated

Enrollment

90Actual

Phase

Phase 1

Conditions

Contraception

Interventions

Placebo: Flexi ring FR01
Placebo: Flexi ring FR20
Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)

Countries

Finland
Netherlands
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

Official Title

A Multi-center, Single-blinded, Randomized, Controlled, Parallel-group Study to Evaluate the Wearing Comfort of Two Different Placebo Intrauterine Systems FR01 and FR20 Compared to a Placebo T-frame Intrauterine System for 3 Cycles in Healthy Women Aged 18-40 Years

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

Jan 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

May 8, 2012

First Submission Date that Met QC Criteria

May 8, 2012

First Posted Date

May 9, 2012Estimated

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 2, 2015

Last Update Posted Date

Apr 3, 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

The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Flexi ring FR01	Placebo Comparator	Drug: Placebo: Flexi ring FR01
Flexi ring FR20	Placebo Comparator	Drug: Placebo: Flexi ring FR20
Ultra low dose LCS	Placebo Comparator	Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo: Flexi ring FR01	Drug	Intrauterine device, inserted once for 3 months	Flexi ring FR01

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Female subject
Age 18-40 years (inclusive)
History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
Confirmed uterine sound depth of 6 to 10 cm

Exclusion Criteria:

Pregnancy or lactation
Sterilized
Nulliparous
Congenital or acquired uterine anomaly
Vaginal or cesarean delivery within 8 weeks prior to insertion

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Helsinki		00100	Finland