Clinical trial NCT00185380: Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 742
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Eligibility criteria: 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.

Primary outcomes:
measure: Pearl Index
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of Subjects With Total or Partial Expulsions
timeFrame: Up to 3 years
measure: Bleeding Pattern by 90-day Reference Periods - Reference Period 1
timeFrame: day 1 to day 90
measure: Bleeding Pattern by 90-day Reference Periods - Reference Period 2
timeFrame: day 91 to day 180
measure: Bleeding Pattern by 90-day Reference Periods - Reference Period 3
timeFrame: day 181 to day 270
measure: Bleeding Pattern by 90-day Reference Periods - Reference Period 4
timeFrame: day 271 to day 360
measure: Bleeding Pattern by 90-day Reference Periods - Reference Period 12
timeFrame: day 991 to day 1080
Other outcomes:
Locations:
city: Espoo
country: Finland
city: Helsinki
country: Finland
city: Joensuu
country: Finland
city: Jyväskylä
country: Finland
city: Kotka
country: Finland
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Turku
country: Finland
city: Turku
country: Finland
city: Bekescsaba
country: Hungary
city: Eger
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szeged
country: Hungary
city: Drammen
country: Norway
city: Elverum
country: Norway
city: Kolbotn
country: Norway
city: Larvik
country: Norway
city: Oslo
country: Norway
city: Trondheim
country: Norway
city: Göteborg
country: Sweden
city: Huddinge
country: Sweden
city: Kalmar
country: Sweden
city: Luleå
country: Sweden
city: Norrköping
country: Sweden
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Örebro
country: Sweden
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Sheffield
country: United Kingdom
state: South Yorkshire
city: Chesterfield
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3. doi: 10.1016/j.fertnstert.2011.12.003. Epub 2012 Jan 4.
citation: Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14.