Trial Condition(s):

Oral Contraceptive

Comparative trial in hormone withdrawal associated symptoms

Bayer Identifier:

14567

ClinicalTrials.gov Identifier:

NCT01076582

EudraCT Number:

2009-014911-11

Study Completed

Trial Purpose

This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.

Inclusion Criteria
- Subjects aged between 18 and 35 years (inclusive)
 - Smokers with a maximum age of 30 years at time of informed consent
 - Healthy female subjects requesting contraception and currently using a low-dose EE containing oral contraceptives (OC) in a 21-day regimen (for at least three months) and suffering from at least two of the hormone withdrawal associated symptoms headache, pelvic pain and bloating during all three months prior the planned baseline cycle and requiring further OC use
 - To be valid for randomization, the total 7-day composite score of hormone-withdrawal symptoms during the baseline cycle must show an increase of at least 50% during Day 22 - 28 versus the 21-day composite score during Day 1 - 21 (21-day score divided by three [for normalization])
 - History of regular cyclic menstrual periods
Exclusion Criteria
- 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, or presence or history of prodrome of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APCresistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
 - History of migraine with focal neurological symptoms.
 - Diabetes mellitus with vascular involvement.
 - Obesity (Body Mass Index >32.0 kg/m2)
 - Moderate to severe hypertension (repeated measurements of systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg).
 - Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
 - Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
 - Jaundice and / or pruritus related to cholestasis (Gilbert´s syndrome excepted), or history of cholestatic jaundice associated with pregnancy or previous combined OC use
 - Severe renal insufficiency or acute renal failure.
 - Presence or history of liver tumors (benign or malignant), or known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).

Trial Summary

Enrollment Goal
592
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Fr. Dr. B. Fechtel

Jena, Germany, 07747

Status
Terminated
 
Locations

Queen Charlottes & Chelseas Hospital

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Nestatni zdravotnicke zarizeni MUDr. Vladimir Dvorak

Brno, Czech Republic, 602 00

Status
Completed
 
Locations

Dr. Smrhova-Kovacs

Tabor, Czech Republic, 39003

Status
Completed
 
Locations

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Sanatorio MAPACI

Rosario, Argentina, 2000

Status
Completed
 
Locations

Hospital Clínico Universidad de Chile

Santiago, Chile, 838-0456

Status
Terminated
 
Locations

Corporación SERJOVEN

Santiago, Chile

Status
Completed
 
Locations

Centro de Investigación Clinica Universidad del Rosario

Bogotá, Colombia

Status
Completed
 
Locations

Endocrinology Scientific Centre

Moscow, Russia, 117036

Status
Terminated
 
Locations

Scientific Research Center of Obst., Gyn. and Perinatology

Moscow, Russia, 177997

Status
Terminated
 
Locations

City Clinical Hospital no 72

Moscow, Russia, 123995

Status
Terminated
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69115

Status
Completed
 
Locations

Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

Status
Terminated
 
Locations

EuromedClinic

Fürth, Germany, 90763

Status
Terminated
 
Locations

Leeds Student Medical Practice

Leeds, United Kingdom, LS2 9AE

Status
Terminated
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

Gynprofi s.r.o.

Praha 2 , Czech Republic, 120 00

Status
Completed
 
Locations

Maternidade Bissaya Barrreto

Coimbra, Portugal, 3000-061

Status
Completed
 
Locations

Hospital de São João

Porto, Portugal, 4200-319

Status
Completed
 
Locations

Hospital Bernardino Rivadavia

Buenos Aires, Argentina, C1425ASQ

Status
Terminated
 
Locations

Consultorio Miraflores

Temuco, Chile, 4790711

Status
Completed
 
Locations

Consultorio Dr. Vera

Santiago, Chile, 7510025

Status
Completed
 
Locations

Fundación Centro de Investigación Clinica

Medellín, Colombia

Status
Completed
 
Locations

Samsung Medical Center

Seoul , South Korea, 135-710

Status
Terminated
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Terminated
 
Locations

Cheil general Hospital

Seoul, South Korea, 100-380

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

The Medical City

Pasig City, Philippines

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

King Chulalongkorn Memorial Hospital

Bangkok, Thailand, 10330

Status
Completed
 
Locations

Prince of Songkla University

Songkla, Thailand, 90110

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Completed
 
Locations

Clínica Santa Sofía

Caracas, Venezuela

Status
Terminated
 
Locations

Policlínica Metropolitana

Caracas, Venezuela

Status
Terminated
 
Locations

Centro Médico Docente La Trinidad

Caracas, Venezuela

Status
Terminated
 
Locations

UP Manila PGH

Manila, Philippines

Status
Completed
 
Locations

May Logan Centre

Liverpool, United Kingdom, L20 5DQ

Status
Completed
 
Locations

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

Magdeburg, Germany, 39126

Status
Completed
 
Locations

Dr. Juan Carolos Montero

Santiago de Chile, Chile

Status
Completed
 
Locations

Instituto Chileno de Medicina Reproductiva

Santiago de Chile, Chile

Status
Completed
 
Locations

Hospital Clínico San Borja Arriarán

Santiago de Chile, Chile, 836-0156

Status
Completed
 
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
 
Locations

ICAMEDIC

Bucaramanga, Colombia

Status
Completed
 
Locations

Clínica Medellín

Medellín, Colombia

Status
Terminated
 
Locations

Clínica del Country

Bogotá, Colombia

Status
Terminated
 

Trial Design