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

PHASE4CompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
ContraceptionMenorrhagia
Interventions
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.

DRUG

Cytotec

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

DRUG

Placebo

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

Trial Locations (17)

20100

Turku

21800

Quetigny

33100

Tampere

40100

Jyväskylä

42300

Roanne

51100

Reims

54042

Nancy

60204

Compiègne

70110

Kuopio

83170

Brignoles

00100

Helsinki

05800

Hyvinkää

Unknown

Mallow

Drogheda

118 83

Stockholm

182 88

Stockholm

S-171 76

Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY