Trial Condition(s):

Oral Contraceptive, Headache, Pelvic Pain

Effect of a new oral contraceptive pill on hormone related symptoms such as pelvic pain and headache

Bayer Identifier:

91550

ClinicalTrials.gov Identifier:

NCT00778609

EudraCT Number:

2008-003226-42

Study Completed

Trial Purpose

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).

Inclusion Criteria
- Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
 - Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least  moderate pelvic pain, headache or both defined by an average value of  >/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
 - Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
 - Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.
Exclusion Criteria
- Women with any contraindication for oral contraceptive use

Trial Summary

Enrollment Goal
449
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Hr. Prof. Dr. H.-J. Ahrendt

Magdeburg, Germany, 39126

Status
Completed
 
Locations

Praxis Hr. Dr. H. Gerlach

Essen, Germany, 45127

Status
Completed
 
Locations

Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

Status
Completed
 
Locations

Praxis Dr. S. Mucha & Dr. G. Schalk

Wuppertal, Germany, 42103

Status
Completed
 
Locations

ClinPharm International GmbH

Dresden, Germany, 01067

Status
Completed
 
Locations

Queen Charlottes & Chelseas Hospital

London, United Kingdom, W12 0NN

Status
Completed
 
Locations

Greenwood and Sneinton Family Medical Centre

Nottingham, United Kingdom, NG2 4PJ

Status
Completed
 
Locations

Maternité Adolphe PINARD

Nancy, France, 54042

Status
Completed
 
Locations

Hôpital Mère et Enfants - CHU NANTES

Nantes, France, 44093

Status
Completed
 
Locations

Dr Matuchansky

Maison Lafitte, France, 78600

Status
Completed
 
Locations

Dr. Jocelyne Nataf-Maurin

Brignoles, France, 83170

Status
Completed
 
Locations

Cabinet Médical - Villersexel - Paris

PARIS, France, 75007

Status
Completed
 
Locations

Cabinet Médical Dr Honthaas, Cohen-Sourdille et De Reilhac

NANTES, France, 44000

Status
Completed
 
Locations

Groupe Médical Ardaens Rohart Dewailly

SECLIN, France, 59113

Status
Completed
 
Locations

Gabinete Médico Velázquez

Madrid, Spain, 28001

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Hospital Integral de la Mujer del Estado de Sonora

Hermosillo, Mexico, 83100

Status
Completed
 
Locations

Centro Médico Del Valle

Mexico, D.F., Mexico, 3100

Status
Completed
 
Locations

Hospital Juárez de México SS

México, D.F., Mexico, 07760

Status
Completed
 
Locations

Nuevo Sanatorio Durango S.A. de C.V.

Mexico, Mexico, 06700

Status
Completed
 
Locations

Queen Elizabeth II Medical Centre

Nedlands, Australia, 6009

Status
Completed
 
Locations

Peninsula Specialist Centre

Kipparing, Australia, 4021

Status
Completed
 
Locations

Caringbah Medical and Dental Centre

Caringbah, Australia, 2229

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Laboratorio Simpanen

Kuopio, Finland, 70100

Status
Completed
 
Locations

Chulalongkorn Hospital

Bangkok , Thailand, 10330

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

Praxis Hr. Dr. T. Gent

Hamburg, Germany, 22359

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

ClinPharm International GmbH&CoKG

Bochum, Germany, 44787

Status
Completed
 
Locations

Praxis Hr. Dr. S. Schönian

Rheinstetten, Germany, 76287

Status
Completed
 
Locations

Praxis Hr. Dr. Werner Göttker-Schnetmann

Frankfurt , Germany, 60322

Status
Completed
 
Locations

ClinPharm International GmbH and Co. KG

Leipzig, Germany, 04103

Status
Completed
 
Locations

Castlemilk Health Centre

Glasgow, United Kingdom, G45 9AW

Status
Completed
 
Locations

Clarence Park Surgery

Weston-super-Mare, United Kingdom, BS23 4BP

Status
Completed
 
Locations

MeDiNova Research

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Bridge House Medical Centre

Cheadle, United Kingdom, SK8 5LL

Status
Completed
 
Locations

Dr Cecile Petrequin

Paris, France, 75018

Status
Completed
 
Locations

Cabinet Médical - Loiret - Olivet

OLIVET, France, 45160

Status
Completed
 
Locations

Cabinet gynecologie

SAINT GERMAIN EN LAYE, France, 78100

Status
Completed
 
Locations

Dr. Gwendoline Servan

TARARE, France, 69170

Status
Completed
 
Locations

Dr. Aliette Siboni-Frisch

Toulouse, France, 31000

Status
Completed
 
Locations

Cabinet médical Dr Patricia Rérolle

PARIS, France, 75015

Status
Completed
 
Locations

Clínica Diatros

Barcelona, Spain, 08013

Status
Completed
 
Locations

Centro de Salud Natahoyo-Tremañes

Gijón, Spain, 33212

Status
Completed
 
Locations

Centro de Salud Rincón de Loix

Benidorm, Spain, 03503

Status
Completed
 
Locations

Centro de Salud Petrer

Petrer, Spain, 03610

Status
Completed
 
Locations

Instituto Mexicano de Investigacion Clinica, SA de CV.

Mexico, Mexico, 06700

Status
Completed
 
Locations

Royal Hospital for Women

Sydney, Australia, 2031

Status
Completed
 
Locations

Family Planning Queensland

Fortitude Valley, Australia, 4006

Status
Completed
 
Locations

King Edward Memorial Hospital

Subiaco, Australia, 6008

Status
Completed
 
Locations

University of Adelaide

Adelaide, Australia, 5005

Status
Completed
 
Locations

Sydney Centre for Reproductive Health Reseach

Ashfield, Australia, 2031

Status
Completed
 
Locations

Burnside Clinical Trials Unit

Norwood, Australia, 5065

Status
Completed
 
Locations

Jean Hailes Foundation for Womens Health

Clayton, Australia, 3163

Status
Completed
 
Locations

ACRO c/- Pacific Medical Centre

Blacktown, Australia, 2148

Status
Completed
 
Locations

Praxis Dr. Christoph Koenig

Bern, Switzerland, 3013

Status
Completed
 
Locations

Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

Status
Completed
 
Locations

Dextra Munkkivuoren Lääkärikeskus Oy

Helsinki, Finland, 00350

Status
Completed
 
Locations

Väestöliitto, Seksuaaliterveysklinikka, Helsinki

Helsinki, Finland, 00100

Status
Completed
 
Locations

Lääkärikeskus Mehiläinen Töölö

Helsinki, Finland, 00260

Status
Completed
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand, 10400

Status
Completed
 

Trial Design