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FR01 and FR20 IUS (Intrauterine System) Wearing Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01595022
First received: May 8, 2012
Last updated: April 1, 2014
Last verified: April 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01595022     History of Changes
Other Study ID Numbers: 13830
Study First Received: May 8, 2012
Last Updated: April 1, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

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

ClinicalTrials.gov processed this record on November 20, 2014