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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Contraception Menorrhagia Drug: Levonorgestrel (Mirena, BAY86-5028) Drug: Cytotec Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 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.
Placebo Comparator: Arm 2 Drug: Cytotec
Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
Active Comparator: Arm 3 Drug: Placebo
Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393198


Locations
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Finland
Helsinki, Finland, 00100
Hyvinkää, Finland, 05800
Jyväskylä, Finland, 40100
Kuopio, Finland, 70110
Tampere, Finland, 33100
Turku, Finland, 20100
France
Brignoles, France, 83170
Compiegne Cedex, France, 60204
Nancy Cedex, France, 54042
Quetigny, France, 21800
Reims, France, 51100
Roanne, France, 42300
Ireland
Mallow, Cork, Ireland
Drogheda, Ireland
Sweden
Stockholm, Sweden, 118 83
Stockholm, Sweden, 182 88
Stockholm, Sweden, S-171 76
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00393198    
Other Study ID Numbers: 91473
2006-000394-30 ( EudraCT Number )
309988 ( Other Identifier: Company internal )
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: November 2, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Intrauterine System
Contraception
Menorrhagia
Additional relevant MeSH terms:
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Menorrhagia
Hemorrhage
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Misoprostol
Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics