FR01 and FR20 IUS (Intrauterine System) Wearing Study
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
1 other identifier
interventional
90
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2010
Shorter than P25 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedApril 3, 2015
April 1, 2015
8 months
May 8, 2012
April 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Flexi ring FR01
PLACEBO COMPARATORFlexi ring FR20
PLACEBO COMPARATORUltra low dose LCS
PLACEBO COMPARATORInterventions
Intrauterine device, inserted once for 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or lactation
- Sterilized
- Nulliparous
- Congenital or acquired uterine anomaly
- Vaginal or cesarean delivery within 8 weeks prior to insertion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (10)
Unknown Facility
Helsinki, 00100, Finland
Unknown Facility
Kuopio, 70110, Finland
Unknown Facility
Tampere, 33100, Finland
Unknown Facility
Turku, 20100, Finland
Unknown Facility
Den Helder, 1780 AT, Netherlands
Unknown Facility
Heerlen, 6401 CX, Netherlands
Unknown Facility
Zwijndrecht, 3331 LZ, Netherlands
Unknown Facility
Örebro, 701 85, Sweden
Unknown Facility
Stockholm, 171 76, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 9, 2012
Study Start
January 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 3, 2015
Record last verified: 2015-04