Trial Condition(s):

Contraception

Dose-finding study for the ultralow-dose levonorgestrel intrauterine contraceptive system (LCS)

Bayer Identifier:

91412

ClinicalTrials.gov Identifier:

NCT00185380

EudraCT Number:

2004-002291-42

Study Completed

Trial Purpose

The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

Inclusion Criteria
- Women with or without children and good general health and in need of contraception.
 - Regular menstrual cycle without hormonal contraceptives.
Exclusion Criteria
- Pregnant or lactating.
 - Last delivery or abortion less than 12 weeks ago.
 - Previous pregnancies outside the womb.
 - Previous pelvic infections.
 - Abnormal bleeding.
 - Abnormal uterine cavity.
 - Climacteric signs.
 - Genital cancer.
 - Liver diseases.
 - Alcoholism or drug abuse.

Trial Summary

Enrollment Goal
742
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Helsinki, Finland, 00260

Status
Completed
 
Locations

Investigative Site

Turku, Finland, 20520

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00100

Status
Completed
 
Locations

Investigative Site

Kuopio, Finland, 70110

Status
Completed
 
Locations

Investigative Site

Tampere, Finland, 33100

Status
Completed
 
Locations

Investigative Site

Lahti, Finland, 15110

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90570

Status
Completed
 
Locations

Investigative Site

Turku, Finland, 20540

Status
Completed
 
Locations

Investigative Site

Szeged, Hungary, 6725

Status
Completed
 
Locations

Investigative Site

Nyiregyhaza, Hungary, 4400

Status
Completed
 
Locations

Investigative Site

Kolbotn, Norway, 1411

Status
Completed
 
Locations

Investigative Site

Trondheim, Norway, 7014

Status
Completed
 
Locations

Investigative Site

Elverum, Norway, 2403

Status
Completed
 
Locations

Investigative Site

Larvik, Norway, 3264

Status
Completed
 
Locations

Investigative Site

Örebro, Sweden, 701 46

Status
Completed
 
Locations

Investigative Site

Luleå, Sweden, 972 33

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90220

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90100

Status
Completed
 
Locations

Keski-Suomen keskussairaala

Jyväskylä, Finland, 40620

Status
Completed
 
Locations

Investigative Site

Espoo, Finland, 02100

Status
Completed
 
Locations

Investigative Site

Turku, Finland, 20100

Status
Completed
 
Locations

Investigative Site

Joensuu, Finland, 80100

Status
Completed
 
Locations

Investigative Site

Kotka, Finland, 48100

Status
Completed
 
Locations

Investigative Site

Bekescsaba, Hungary, 5600

Status
Completed
 
Locations

Investigative Site

Eger, Hungary, 3300

Status
Completed
 
Locations

Investigative Site

Drammen, Norway, 3001

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0309

Status
Completed
 
Locations

Investigative Site

Huddinge, Sweden, 14186

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 411 35

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, S-171 76

Status
Completed
 
Locations

Investigative Site

Umeå, Sweden, 90185

Status
Completed
 
Locations

Investigative Site

Kalmar, Sweden, 39231

Status
Completed
 
Locations

Investigative Site

Chesterfield, United Kingdom, S40 1SX

Status
Completed
 
Locations

Investigative Site

Norrköping, Sweden, 602 22

Status
Completed
 
Locations

Avondale Surgery

Chesterfield, United Kingdom, S40 4TF

Status
Completed
 
Locations

Investigative Site

Sheffield, United Kingdom, S1 2PJ

Status
Completed
 

Trial Design