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FR01 and FR20 IUS (Intrauterine System) Wearing Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595022
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Placebo: Flexi ring FR01 Drug: Placebo: Flexi ring FR20 Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Study Start Date : January 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Flexi ring FR01 Drug: Placebo: Flexi ring FR01
Intrauterine device, inserted once for 3 months
Placebo Comparator: Flexi ring FR20 Drug: Placebo: Flexi ring FR20
Intrauterine device, inserted once for 3 months
Placebo Comparator: Ultra low dose LCS Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)
Intrauterine device, inserted once for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain) [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595022


Locations
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Finland
Helsinki, Finland, 00100
Kuopio, Finland, 70110
Tampere, Finland, 33100
Turku, Finland, 20100
Netherlands
Den Helder, Netherlands, 1780 AT
Heerlen, Netherlands, 6401 CX
Zwijndrecht, Netherlands, 3331 LZ
Sweden
Stockholm, Sweden, 171 76
Uppsala, Sweden, 75185
Örebro, Sweden, 701 85
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01595022    
Other Study ID Numbers: 13830
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
 Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral