FR01 and FR20 IUS (Intrauterine System) Wearing Study

Bayer90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Contraception

Interventions

Placebo: Flexi ring FR01DRUG

Intrauterine device, inserted once for 3 months

Placebo: Flexi ring FR20DRUG

Intrauterine device, inserted once for 3 months

Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)DRUG

Intrauterine device, inserted once for 3 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Helsinki, Finland

Unnamed facility

Kuopio, Finland

Unnamed facility

Tampere, Finland

Unnamed facility

Turku, Finland

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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