Phase 2
N=742
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00185380 ↗Enrolled (actual)
742
Serious AEs
5.4%
Results posted
Mar 2010
Primary outcome: Primary: Pearl Index — 0.17; 0.82; 0.00 Number per 100 women years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levonorgestrel IUS (BAY86-5028, G04209B) (Drug); Levonorgestrel IUS (BAY86-5028, G04209C) (Drug); Levonorgestrel IUS (Mirena, BAY86-5028) (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pearl Index |
0.17; 0.82; 0.00 | — |
| SECONDARY Number of Subjects With Total or Partial Expulsions |
0; 3; 0; 1; 2; 4 | — |
| SECONDARY Bleeding Pattern by 90-day Reference Periods - Reference Period 1 |
15.1; 15.4; 14.3; 39.9; 39.2; 36.6 | — |
| SECONDARY Bleeding Pattern by 90-day Reference Periods - Reference Period 2 |
8.2; 7.7; 7.6; 22.6; 21.8; 21.8 | — |
| SECONDARY Bleeding Pattern by 90-day Reference Periods - Reference Period 3 |
6.4; 5.4; 5.3; 18.3; 16.7; 16.8 | — |
| SECONDARY Bleeding Pattern by 90-day Reference Periods - Reference Period 4 |
5.5; 4.7; 4.2; 16.7; 15.0; 15.2 | — |
| SECONDARY Bleeding Pattern by 90-day Reference Periods - Reference Period 12 |
3.6; 3.0; 1.9; 12.8; 10.6; 8.8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00185380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.