check_circleStudy Completed

Contraception

Bayer Identifier:

13830

ClinicalTrials.gov Identifier:

NCT01595022

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

Female

Age

18 - 40 Years
  • - 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
  • - Pregnancy or lactation
    - Sterilized
    - Nulliparous
    - Congenital or acquired uterine anomaly
    - Vaginal or cesarean delivery within 8 weeks prior to insertion

Trial summary

Enrollment Goal
90
Trial Dates
January 2010 - September 2010
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Levonorgestrel FlexiRing (BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Atrium Medisch CentrumHEERLEN, 6401 CX, Netherlands
Completed
Albert Schweitzer Ziekenhuis, locatie ZwijndrechtZWIJNDRECHT, 3331 LZ, Netherlands
Completed
Gemini ZiekenhuisDen Helder, 1780 AT, Netherlands
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Akademiska SjukhusetUppsala, 75185, Sweden
Completed
UniversitetssjukhusetÖrebro, 701 85, Sweden
Completed
Väestöliitto, Seksuaaliterveysklinikka, HelsinkiHelsinki, 00100, Finland
Completed
Lääkäriasema PulssiTurku, 20100, Finland
Completed
Suomen Terveystalo TampereTampere, 33100, Finland
Completed
Lääkäriasema Cantti OyKuopio, 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 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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