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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00393198

Collaborator

(none)

204

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

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 :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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.

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

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Helsinki		Finland	00100
2	Hyvinkää		Finland	05800
3	Jyväskylä		Finland	40100
4	Kuopio		Finland	70110
5	Tampere		Finland	33100
6	Turku		Finland	20100
7	Brignoles		France	83170
8	Compiegne Cedex		France	60204
9	Nancy Cedex		France	54042
10	Quetigny		France	21800
11	Reims		France	51100
12	Roanne		France	42300
13	Mallow	Cork	Ireland
14	Drogheda		Ireland
15	Stockholm		Sweden	118 83
16	Stockholm		Sweden	182 88
17	Stockholm		Sweden	S-171 76