Clinical trial NCT00393198: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Menorrhagia
Keywords: Intrauterine System
Contraception
Menorrhagia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-10-27
Enrollment: 204
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary efficacy variable will be bleeding profile
timeFrame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
Secondary outcomes:
measure: Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
timeFrame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Hyvinkää
country: Finland
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Brignoles
country: France
city: Compiegne Cedex
country: France
city: Nancy Cedex
country: France
city: Quetigny
country: France
city: Reims
country: France
city: Roanne
country: France
city: Mallow
country: Ireland
state: Cork
city: Drogheda
country: Ireland
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.