Comparative Trial in Hormone Withdrawal Associated Symptoms

NCT ID: NCT01076582

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 592 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-10-31

Brief Summary

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.

Conditions

Oral Contraceptive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

EE20/DRSP (YAZ, BAY86-5300)

Intervention Type: DRUG

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days

Arm 2

Group Type: ACTIVE_COMPARATOR

Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)

Intervention Type: DRUG

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Interventions

EE20/DRSP (YAZ, BAY86-5300)

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days

Intervention Type: DRUG

Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Rosario, Santa Fe Province, Argentina

Santiago, Santiago Metropolitan, Chile

Santiago, Santiago Metropolitan, Chile

Santiago, , Chile

Santiago, , Chile

Temuco, , Chile

Bucaramanga, Santander Department, Colombia

Bogotá, , Colombia

Medellín, , Colombia

Brno, , Czechia

Prague, , Czechia

Tábor, , Czechia

Heidelberg, Baden-Wurttemberg, Germany

Fürth, Bavaria, Germany

Hanover, Lower Saxony, Germany

Leipzig, Saxony, Germany

Magdeburg, Saxony-Anhalt, Germany

Jena, Thuringia, Germany

Florence, , Italy

Milan, , Italy

Siena, , Italy

Manila, , Philippines

Pasig, , Philippines

Lisbon, Lisbon District, Portugal

Coimbra, , Portugal

Porto, , Portugal

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Seoul, Korea, South Korea

Seoul, Korea, South Korea

Seoul, , South Korea

Seoul, , South Korea

Basel, Canton of Basel-City, Switzerland

Bern, Canton of Bern, Switzerland

Sankt Gallen, Canton of St. Gallen, Switzerland

Bangkok, Thailand, Thailand

Songkhla, Thailand, Thailand

Bangkok, , Thailand

Leeds, West Yorkshire, United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

Caracas, , Venezuela

Countries

Argentina; Chile; Colombia; Czechia; Germany; Italy; Philippines; Portugal; Russia; South Korea; Switzerland; Thailand; United Kingdom; Venezuela

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2009-014911-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14567

Identifier Type: -

Identifier Source: org_study_id