FR01 and FR20 IUS (Intrauterine System) Wearing Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595022
• Other study ID #: 13830
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2012
• Last updated: April 2, 2015
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: April 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Placebo: Flexi ring FR01
Intrauterine device, inserted once for 3 months
• Placebo: Flexi ring FR20
Intrauterine device, inserted once for 3 months
• Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)
Intrauterine device, inserted once for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Finland,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

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