Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

Bayer

Status and phase: Completed; Phase 3

Conditions: Menopause

Treatments: Drug: LNG IUS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185458

90660

300400 (Other Identifier)

Details and patient eligibility

About

The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Enrollment: 394 patients

Sex: Female

Ages: 46 to 51 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

Exclusion criteria

• Pregnancy or lactation.
• Previous pelvic infections.
• Abnormal bleeding.
• Abnormal uterine cavity.
• Uterine polyps.
• Genital cancer.
• Liver diseases.
• Alcoholism or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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394 participants in 1 patient group

LNG IUS

Experimental group

Description:

Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

Treatment:

Drug: LNG IUS