Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

Contraception Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185380
• Other study ID #: 91412
• Secondary ID: 2004-002291-4230
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 15, 2015
• Start date: April 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyHungary: National Institute of PharmacyLithuania: State Medicine Control Agency - Ministry of HealthNorway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUS (BAY86-5028, G04209B)
Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
• Levonorgestrel IUS (BAY86-5028, G04209C)
Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
• Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Finland,  Hungary,  Norway,  Sweden,  United Kingdom, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pearl Index	The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.	Up to 3 years	No
Secondary	Number of Subjects With Total or Partial Expulsions	The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.	Up to 3 years	No
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 1	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.	day 1 to day 90	No
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 2	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.	day 91 to day 180	No
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 3	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.	day 181 to day 270	No
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 4	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.	day 271 to day 360	No
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 12	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.	day 991 to day 1080	No

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