Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age - LCS Pearl Index Study

• Register: EUCTR
• Last refreshed on: 16 September 2013
• Main ID: EUCTR2007-000420-40-HU
• Date of registration: 04/07/2007
• Prospective Registration: Yes
• Primary sponsor: Bayer Schering Pharma Oy
• Public title: Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age - LCS Pearl Index Study
• Scientific title: Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age - LCS Pearl Index Study
• Date of first enrolment: 04/10/2007
• Target sample size: 2820
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000420-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: two doses

Countries of recruitment

Finland, France, Hungary, Netherlands, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Has signed informed consent.
2. Is of age between 18 and 35 years (inclusive), in good general health and requesting contraception.
3. Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
4. Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
5. Is willing and able to attend the scheduled visits and to comply with the study procedures.
Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

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:
1. Known or suspected pregnancy or is lactating.
2. Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 1.
3. History of ectopic pregnancies.
4. Infected abortion or postpartum endometritis within 3 months prior to visit 1.
5. Abnormal uterine bleeding of unknown origin.
6. Any genital infection (until successfully treated).
7. Descriptive diagnoses of epithelial cell atypias (not benign atypias) or more serious disorder in cervical smear (according to the Bethesda System) at screening and not responding to treatment.
8. History of, or current, pelvic inflammatory disease.
9. Congenital or acquired uterine anomaly.
10. Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
11. History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
12. Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
13. Current endometrial polyp(s).
14. Ovarian cyst(s) with diameter > 3 cm.
15. Concomitant use of other sex-hormone containing preparations or intrauterine device.
16. Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication,
and if entering subset 2 or subset 3: any sex-hormone administration within one month prior to start of the study medication
17. If entering subset 2: any drug that might affect the blood coagulation (e.g., heparin, coumarin) within one month prior to start of the study medication
18. If entering subset 2: any known condition that might affect the blood coagulation.
19. Established immunodeficiency.
20. Any known hypersensitivity to the constituents of the LCS.
21. Diagnosed or suspected malignant or premalignant disease at the screening.
22. Arterial hypertension not responding to treatment, with systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg.
23. Current (or history of) severe hepatic diseases including benign or malignant tumors. There should be an interval of at least 3 months between the start of study treatment (i.e., LCS insertion) and the return of liver function values to normal.
24. History of chronic alcoholism, drug dependence or abuse, psychotic states or severe neurosis or any other condition that, by judgment of the investigator, might impair subject's ability to cooperate.
25. Known or suspected HIV infection or high risk for STD.
26. Any clinically significant condition or laboratory result that, in the opinion of the investigator, compromises subject’s safety, might interfere with the evaluations or prevents the completion of the study. Non-inclusion laboratory values will be flagged by the laboratory based on predefined ranges .
27. Participated in another clinical study or consumed another experimental drug within 1 month prior to visit 1.
28. Previous participation in this study.
A person with close affiliation with the investigational site; e.g., close relative of the investigator, dependent person, employee or student of the investigational site.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Contraception
MedDRA version: 9.1 Level: PT Classification code 10010808 Term: Contraception

Intervention(s)

Product Name: LCS (Ultra low dose Levonorgestrel Contraceptive System)
Product Code: SH G04209F/G
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: levonorgestrel
CAS Number: 797-63-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 13.5 , 19.5-

Primary Outcome(s)

Main Objective: The main objective of this study is to assess the safety and efficacy of 2 doses of LNG, delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 35 years of age.

Primary end point(s): Pregnancy rate

Secondary Objective: To assesss the pharmacokinetics of the 2 doses

Secondary ID(s)

310442

2007-000420-40-FI