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

NCT ID: NCT00393198

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Contraception; Menorrhagia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Levonorgestrel (Mirena, BAY86-5028)

Intervention Type: DRUG

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.

Arm 2

Group Type: PLACEBO_COMPARATOR

Cytotec

Intervention Type: DRUG

Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit

Arm 3

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Interventions

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.

Intervention Type: DRUG

Cytotec

Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit

Intervention Type: DRUG

Placebo

Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Helsinki, , Finland

Hyvinkää, , Finland

Jyväskylä, , Finland

Kuopio, , Finland

Tampere, , Finland

Turku, , Finland

Brignoles, , France

Compiègne, , France

Nancy, , France

Quetigny, , France

Reims, , France

Roanne, , France

Mallow, Cork, Ireland

Drogheda, , Ireland

Stockholm, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Countries

Finland; France; Ireland; Sweden

References

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.

Reference Type: RESULT

PMID: 20472114 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19955104 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20378611 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24682613 (View on PubMed)

Other Identifiers

2006-000394-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

309988

Identifier Type: OTHER

Identifier Source: secondary_id

91473

Identifier Type: -

Identifier Source: org_study_id