Trial Condition(s):

Primary Dysmenorrhea

Effect on primary dysmenorrhea

Bayer Identifier:

91781

ClinicalTrials.gov Identifier:

NCT00909857

EudraCT Number:

2008-005625-11

Study Completed

Trial Purpose

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Inclusion Criteria
- Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
 - Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
 - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
 - Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
 - Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Exclusion Criteria
- Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
 - Obesity: body mass index (BMI) > 32 kg/m2
 - Hypersensitivity to any of the study drug ingredients
 - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
 - Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
 - Abuse of alcohol, drugs, or medicines (e.g. laxatives)
 - Other contraceptive methods:
 -- Sterilization
 -- Oral, vaginal or transdermal hormonal contraception during treatment
 -- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
 - Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
 - Major surgery scheduled for the study period

Trial Summary

Enrollment Goal
507
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Freiburg

Freiburg, Germany, 79106

Status
Completed
 
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
 
Locations

Evangelisches Krankenhaus Köln Weyertal gGmbH

Köln, Germany, 50931

Status
Completed
 
Locations

Mount Vernon Clinical Research, LLC

Sandy Springs, United States, 30328

Status
Completed
 
Locations

Rosemark Women Care Specialist

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Clinical Trials Research Services, LLC

Pittsburgh, United States, 15206

Status
Completed
 
Locations

AGA Clinical Trials

Hialeah, United States, 33012

Status
Completed
 
Locations

University of Wisconsin - La Crosse

La Crosse, United States, 54691

Status
Completed
 
Locations

Lyndhurst Clinical Research

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Azienda Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

A.O.U. di Bologna

Bologna, Italy, 40138

Status
Completed
 
Locations

AUSL Brindisi - Puglia

Francavilla Fontana, Italy, 72021

Status
Completed
 
Locations

St. Michael's Hospital Health Centre

Toronto, Canada, M5C 2T2

Status
Completed
 
Locations

Praxis Hr. Dr. H. Gerlach

Essen, Germany, 45127

Status
Completed
 
Locations

Praxis Hr. Dr. K. Peters

Hamburg, Germany, 22159

Status
Completed
 
Locations

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

Magdeburg, Germany, 39126

Status
Completed
 
Locations

Praxis Fr. A. Heweker

Bernburg, Germany, 06406

Status
Completed
 
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
 
Locations

Office of Dr. Alfred Moffett, MD

Leesburg, United States, 34748

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Genova Clinical Research, Inc.

Tucson, United States, 85741

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Completed
 
Locations

A.O. OIRM - S.Anna

Torino, Italy, 10126

Status
Completed
 
Locations

A.O. Spedali Civili

Brescia, Italy, 25123

Status
Completed
 
Locations

A.O. Fatebenefratelli e Oftalmico

Milano, Italy, 20121

Status
Completed
 
Locations

A.O.U. di Perugia

Perugia, Italy, 06156

Status
Completed
 
Locations

Glover Medical Clinic

Langley, Canada, V3A 4H9

Status
Completed
 
Locations

Regina Medical Centre

Regina, Canada, S4P 3X1

Status
Terminated
 
Locations

Consultorio del Dr. Castiglione

Santiago, Chile

Status
Completed
 
Locations

Clínica Las Condes

Santiago de Chile, Chile

Status
Completed
 
Locations

Instituto Chileno de Medicina Reproductiva

Santiago de Chile, Chile

Status
Completed
 
Locations

Hospital Clínico Universidad de Chile

Santiago, Chile

Status
Terminated
 
Locations

Philippine General Hospital

Metro Manila, Philippines, 1000

Status
Completed
 
Locations

Hospice and Palliative Cener

Cebu City, Philippines

Status
Terminated
 
Locations

Clinique Médicale des Campus

Ste-Foy, Canada, G1V 4X7

Status
Completed
 
Locations

Kells Medical Research Group, Inc.

Pointe-Claire, Canada, H9R 4S3

Status
Completed
 
Locations

Universidad de Concepcion Hospital Las Higueras

Talcahuano, Chile

Status
Completed
 
Locations

Consultorio Miraflores

Temuco, Chile, 4790711

Status
Completed
 
Locations

Manila Doctors Hospital

Metro Manila, Philippines

Status
Terminated
 
Locations

Chong Hua Hospital

Cebu, Philippines

Status
Completed
 
Locations

St. Luke’s Medical Center

Quezon City, Philippines

Status
Completed
 
Locations

Medical Tower

Davao, Philippines

Status
Completed
 

Trial Design