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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

About this trial

This is an interventional treatment trial for Contraception focused on measuring Intrauterine System, Contraception, Menorrhagia

Eligibility Criteria

23 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT00393198

First Posted

October 26, 2006

Last Updated

October 31, 2014

Sponsor

Bayer

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

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

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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