Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

PHASE3CompletedINTERVENTIONAL
Enrollment

449

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Oral ContraceptiveHeadachePelvic Pain
Interventions
DRUG

EV/DNG (Qlaira, BAY86-5027)

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval

DRUG

Encapsulated Microgynon + Placebo

Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

Trial Locations (63)

2031

Ashfield

Sydney

2148

Blacktown

2229

Caringbah

3010

Bern

3013

Bern

3100

Mexico City

3163

Clayton

4006

Fortitude Valley

4021

Kipparing

4031

Basel

5005

Adelaide

5065

Norwood

6008

Subiaco

6009

Nedlands

8091

Zurich

10330

Bangkok

10400

Bangkok

10700

Bangkok

22359

Hamburg

23538

Lübeck

28001

Madrid

30459

Hanover

31000

Toulouse

33212

Gijón

39126

Magdeburg

42103

Wuppertal

44000

Nantes

44093

Nantes

44787

Bochum

45127

Essen

45160

Olivet

54042

Nancy

59113

Seclin

60322

Frankfurt am Main

69170

Tarare

70100

Kuopio

70110

Kuopio

75007

Paris

75015

Paris

75018

Paris

76287

Rheinstetten

78100

Saint-Germain-en-Laye

78600

Maison Lafitte

83100

Hermosillo

83170

Brignoles

00100

Helsinki

00260

Helsinki

00350

Helsinki

01067

Dresden

04103

Leipzig

06700

México

07760

México, D.F.

03503

Benidorm

03610

Petrel

08013

Barcelona

08003

Barcelona

SK8 5LL

Cheadle

HA6 2RN

Northwood

BS23 4BP

Weston-super-Mare

NG2 4PJ

Nottingham

G45 9AW

Glasgow

W12 0NN

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00778609 - Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache | Biotech Hunter | Biotech Hunter