check_circleStudy Completed
Contraception
Bayer Identifier:
13830
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
FR01 and FR20 IUS (intrauterine system) wearing study
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
18 - 40 YearsTrial summary
Enrollment Goal
90Trial Dates
January 2010 - September 2010Phase
Phase 1Could I Receive a placebo
YesProducts
Levonorgestrel FlexiRing (BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Atrium Medisch Centrum | HEERLEN, 6401 CX, Netherlands |
Completed | Albert Schweitzer Ziekenhuis, locatie Zwijndrecht | ZWIJNDRECHT, 3331 LZ, Netherlands |
Completed | Gemini Ziekenhuis | Den Helder, 1780 AT, Netherlands |
Completed | Karolinska Universitetssjukhuset i Solna | Stockholm, 171 76, Sweden |
Completed | Akademiska Sjukhuset | Uppsala, 75185, Sweden |
Completed | Universitetssjukhuset | Örebro, 701 85, Sweden |
Completed | Väestöliitto, Seksuaaliterveysklinikka, Helsinki | Helsinki, 00100, Finland |
Completed | Lääkäriasema Pulssi | Turku, 20100, Finland |
Completed | Suomen Terveystalo Tampere | Tampere, 33100, Finland |
Completed | Lääkäriasema Cantti Oy | Kuopio, 70110, Finland |
Primary Outcome
- Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)date_rangeTime Frame:3 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
3