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

PHASE3CompletedINTERVENTIONAL
Enrollment

394

Participants

Timeline

Start Date

May 31, 2000

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Menopause
Interventions
DRUG

LNG IUS

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) 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 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.

Trial Locations (12)

4500

Huy

9000

Ghent

20100

Turku

20520

Turku

02100

Espoo

6419 PC

Heerlen

5912 BL

Venlo

1502 DV

Zaandam

3331 LZ

Zwijndrecht

CB23 2TN

Cambridge

BH15 2JB

Poole

NE4 6BE

Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY