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

Bayer

Status and phase: Completed; Phase 4

Conditions: Contraception; Menorrhagia

Treatments: Drug: Levonorgestrel (Mirena, BAY86-5028); Drug: Cytotec; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393198

309988 (Other Identifier)

2006-000394-30 (EudraCT Number)

91473

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: Female

Ages: 23 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Levonorgestrel (Mirena, BAY86-5028)

Arm 2

Placebo Comparator group

Treatment:

Drug: Cytotec

Arm 3

Active Comparator group

Treatment:

Drug: Placebo