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OpenTrials
Completed

NCT Number: NCT01595022

FR01 and FR20 IUS (Intrauterine System) Wearing Study

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.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo: Flexi ring FR01

Drug

Intrauterine device, inserted once for 3 months

Placebo: Flexi ring FR20

Drug

Intrauterine device, inserted once for 3 months

Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)

Drug

Intrauterine device, inserted once for 3 months

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 9, 2012
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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