Multi-center, open, randomized, dose finding phase II study to investigate for a maximum of three years ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) releasing in vitro 12 µg/24 h and 16 µg/24 h of levonorgestrel compared to MIRENA in nulliparous and parous women in need of contraception

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002291-42-FI

Enrollment

690

Registered

2004-11-23

Start date

2005-03-17

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception MedDRA version: 7.0 Level: LLT Classification code 10010808

Interventions

Product Name: LCS (Ultra low dose Levonorgestrel Contraceptive System) Product Code: SH G04209B/C Pharmaceutical Form: Intrauterine delivery system INN or Proposed INN: Levonorgestrel CAS Number: 797-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Generally healthy 21-40 years old parous or non-parous fertile women with endogenous cyclicity and in need of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Suspected pregnancy or lactation; less than 12 weeks since abortion or delivery; history of ectopic pregnancies; any current genital infection or history of pelvic inflammatory disease; abnormal bleeding of unknown origin; any distortion of the uterine cavity; epithelial cell atypias in cervical smear; history or current/suspicion of genital malignancy; diagnosed/suspected malignant disease; severe hepatic diseases; current endometrial polyps; ovarian cysts > 3 cm; high risk for sexually transmitted disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to search for an appropriate levonorgestrel dose for a new contraceptive intrauterine system (IUS) suitable for use by non-parous and parous women.;Secondary Objective: To determine efficacy, safety, pharmacokinetic and pharmacodynamic related characteristics of the product/dose by studying the following: IUS expulsion rate, subject discontinuation rate for (non-)bleeding problems, overall discontinuation rate, progestin-related side effects, dysmenorrhea, bleeding pattern, IUS insertion and removal ease and pain and in smaller subsets (in Finland only) ovarian and cervical function, endometrial histology and pharmacokinetics.;Primary end point(s): Pregnancy rate.	—

Measure

Time frame

Main Objective: The objective of this study is to search for an appropriate levonorgestrel dose for a new contraceptive intrauterine system (IUS) suitable for use by non-parous and parous women.;Secondary Objective: To determine efficacy, safety, pharmacokinetic and pharmacodynamic related characteristics of the product/dose by studying the following: IUS expulsion rate, subject discontinuation rate for (non-)bleeding problems, overall discontinuation rate, progestin-related side effects, dysmenorrhea, bleeding pattern, IUS insertion and removal ease and pain and in smaller subsets (in Finland only) ovarian and cervical function, endometrial histology and pharmacokinetics.;Primary end point(s): Pregnancy rate.

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Countries

Finland, Hungary, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026