Trial Condition(s):

Contraception

FR01 and FR20 IUS (intrauterine system) wearing study

Bayer Identifier:

13830

ClinicalTrials.gov Identifier:

NCT01595022

EudraCT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
90
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
Yes
Products
Levonorgestrel FlexiRing (BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Atrium Medisch Centrum

HEERLEN, Netherlands, 6401 CX

Status
Completed
 
Locations

Albert Schweitzer Ziekenhuis, locatie Zwijndrecht

ZWIJNDRECHT, Netherlands, 3331 LZ

Status
Completed
 
Locations

Gemini Ziekenhuis

Den Helder, Netherlands, 1780 AT

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 75185

Status
Completed
 
Locations

Universitetssjukhuset

Örebro, Sweden, 701 85

Status
Completed
 
Locations

Väestöliitto, Seksuaaliterveysklinikka, Helsinki

Helsinki, Finland, 00100

Status
Completed
 
Locations

Lääkäriasema Pulssi

Turku, Finland, 20100

Status
Completed
 
Locations

Suomen Terveystalo Tampere

Tampere, Finland, 33100

Status
Completed
 
Locations

Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

Status
Completed
 

Trial Design