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FR01 and FR20 IUS (Intrauterine System) Wearing Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01595022
First received: May 8, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595022

Locations
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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01595022     History of Changes
Other Study ID Numbers: 13830
Study First Received: May 8, 2012
Last Updated: March 20, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013