Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
Primary Purpose
Contraception, Menorrhagia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Levonorgestrel (Mirena, BAY86-5028)
Cytotec
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Contraception focused on measuring Intrauterine System, Contraception, Menorrhagia
Eligibility Criteria
Inclusion Criteria:
- Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
- Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
- Clinically normal cervical smear result within 12 preceding months or at screening.
- Clinically normal breast examination findings. For patients >/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.
Exclusion Criteria:
- Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
- Known or suspected pregnancy.
- Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
- Current or recurrent pelvic inflammatory disease.
- Abnormal uterine bleeding of unknown origin.
- Acute cervicitis or vaginitis not responding to treatment.
- History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
- Any active acute liver disease or liver tumor.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
Primary efficacy variable will be bleeding profile
Secondary Outcome Measures
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00393198
Brief Title
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
Official Title
Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
Detailed Description
This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Menorrhagia
Keywords
Intrauterine System, Contraception, Menorrhagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Title
Arm 3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel (Mirena, BAY86-5028)
Intervention Description
Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.
Intervention Type
Drug
Intervention Name(s)
Cytotec
Intervention Description
Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
Primary Outcome Measure Information:
Title
Primary efficacy variable will be bleeding profile
Time Frame
Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
Secondary Outcome Measure Information:
Title
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
Time Frame
Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
Clinically normal cervical smear result within 12 preceding months or at screening.
Clinically normal breast examination findings. For patients >/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.
Exclusion Criteria:
Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
Known or suspected pregnancy.
Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
Current or recurrent pelvic inflammatory disease.
Abnormal uterine bleeding of unknown origin.
Acute cervicitis or vaginitis not responding to treatment.
History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
Any active acute liver disease or liver tumor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
City
Hyvinkää
ZIP/Postal Code
05800
Country
Finland
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
City
Tampere
ZIP/Postal Code
33100
Country
Finland
City
Turku
ZIP/Postal Code
20100
Country
Finland
City
Brignoles
ZIP/Postal Code
83170
Country
France
City
Compiegne Cedex
ZIP/Postal Code
60204
Country
France
City
Nancy Cedex
ZIP/Postal Code
54042
Country
France
City
Quetigny
ZIP/Postal Code
21800
Country
France
City
Reims
ZIP/Postal Code
51100
Country
France
City
Roanne
ZIP/Postal Code
42300
Country
France
City
Mallow
State/Province
Cork
Country
Ireland
City
Drogheda
Country
Ireland
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
20472114
Citation
Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1. Erratum In: Contraception. 2023 Mar;119:109926.
Results Reference
result
PubMed Identifier
19955104
Citation
Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.
Results Reference
result
PubMed Identifier
20378611
Citation
Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.
Results Reference
result
PubMed Identifier
24682613
Citation
Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.
Results Reference
derived
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Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
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