Trial Condition(s):
Contraception
Dose-finding study for the ultralow-dose levonorgestrel intrauterine contraceptive system (LCS)
Bayer Identifier:
91412
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Helsinki, Finland, 00260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kuopio, Finland, 70110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lahti, Finland, 15110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90570 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20540 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nyiregyhaza, Hungary, 4400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kolbotn, Norway, 1411 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trondheim, Norway, 7014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elverum, Norway, 2403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Larvik, Norway, 3264 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Örebro, Sweden, 701 46 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Luleå, Sweden, 972 33 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Keski-Suomen keskussairaala Jyväskylä, Finland, 40620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Espoo, Finland, 02100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joensuu, Finland, 80100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kotka, Finland, 48100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bekescsaba, Hungary, 5600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eger, Hungary, 3300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Drammen, Norway, 3001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oslo, Norway, 0309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Huddinge, Sweden, 14186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 411 35 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, S-171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 90185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kalmar, Sweden, 39231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S40 1SX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Norrköping, Sweden, 602 22 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Avondale Surgery Chesterfield, United Kingdom, S40 4TF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sheffield, United Kingdom, S1 2PJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multi-center, open, randomized, dose finding phase II study to investigate ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) releasing different amounts of levonorgestrel compared to MIRENA in nulliparous and parous women in need of contraception.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Pearl IndexTimeframe: Up to 3 years
Secondary Outcome
- Number of Subjects With Total or Partial ExpulsionsTimeframe: Up to 3 years
- Bleeding Pattern by 90-day Reference Periods - Reference Period 1Timeframe: day 1 to day 90
- Bleeding Pattern by 90-day Reference Periods - Reference Period 2Timeframe: day 91 to day 180
- Bleeding Pattern by 90-day Reference Periods - Reference Period 3Timeframe: day 181 to day 270
- Bleeding Pattern by 90-day Reference Periods - Reference Period 4Timeframe: day 271 to day 360
- Bleeding Pattern by 90-day Reference Periods - Reference Period 12Timeframe: day 991 to day 1080
Additional Information
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