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

Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00393198

Enrollment

204

Registered

2006-10-27

Start date

2006-10-31

Completion date

2012-10-31

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Menorrhagia

Keywords

Intrauterine System, Contraception, 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.

Interventions

DRUGLevonorgestrel (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.

DRUGCytotec

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

DRUGPlacebo

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

23 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Primary efficacy variable will be bleeding profile	Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5

Secondary

Measure	Time frame
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction	Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5

Countries

Finland, France, Ireland, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026