Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

• ClinicalTrials.gov Identifier: NCT00393198
• Recruitment Status: Completed
• First Posted: October 27, 2006
• Last Update Posted: November 2, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: October 26, 2006
• First Posted Date: October 27, 2006
• Last Update Posted Date: November 2, 2014
• Study Start Date: October 2006
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 30, 2008): 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 ]
• Original Primary Outcome Measures (submitted: October 26, 2006): Primary efficacy variable will be bleeding profile
• Current Secondary Outcome Measures (submitted: September 30, 2008): 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 ]
• Original Secondary Outcome Measures (submitted: October 26, 2006): Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Contraception
• Menorrhagia

Intervention

• Drug: Levonorgestrel (Mirena, BAY86-5028)
  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.
• Drug: Cytotec
  Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
• Drug: Placebo
  Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Study Arms

• Experimental: Arm 1
  Intervention: Drug: Levonorgestrel (Mirena, BAY86-5028)
• Placebo Comparator: Arm 2
  Intervention: Drug: Cytotec
• Active Comparator: Arm 3
  Intervention: Drug: Placebo

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 18, 2013): 204
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 23 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland, France, Ireland, Sweden

Administrative Information

• NCT Number: NCT00393198
• Other Study ID Numbers: 91473; 2006-000394-30 ( EudraCT Number ); 309988 ( Other Identifier: Company internal )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bayer
• Original Responsible Party: Not Provided
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: October 2014