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FR01 and FR20 IUS (Intrauterine System) Wearing Study

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01595022
Enrollment
90
Registered
2012-05-09
Start date
2010-01-31
Completion date
2010-09-30
Last updated
2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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.

Interventions

DRUGPlacebo: Flexi ring FR01

Intrauterine device, inserted once for 3 months

DRUGPlacebo: Flexi ring FR20

Intrauterine device, inserted once for 3 months

DRUGPlacebo: Ultra low dose levonorgestrel contraceptive system (LCS)

Intrauterine device, inserted once for 3 months

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)3 months

Countries

Finland, Netherlands, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026