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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-002291-42-SE |
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Date of registration:
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24/11/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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13/04/2005 |
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Target sample size:
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690 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002291-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Finland
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Hungary
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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:
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Contraception
MedDRA version: 7.0
Level: LLT
Classification code 10010808
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Intervention(s)
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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: 797-63-7
Current Sponsor code: ZK 18206
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 13, 19-
Product Name: MIRENA
Product Code: SH G00650AD
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: Levonorgestrel
CAS Number: 797-63-7
Current Sponsor code: ZK 18206
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 52-
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Primary Outcome(s)
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Primary end point(s): Pregnancy rate.
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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.
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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.
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Secondary ID(s)
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308901
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2004-002291-42-FI
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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