stop_circleTerminated/Withdrawn

Contraception

Bayer Identifier:

14700

ClinicalTrials.gov Identifier:

NCT01331655

EudraCT Number:

Not Available

EU CT Number:

Not Available
Clinical study of a conventional and flexible extended oral contraceptive of EE/DRSP with or without Metafolin in Latin America

Trial purpose

The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection
  • - Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
    - Body mass index (BMI) >/= 30.0 kg/m2
    - Presence or a history of venous or arterial thrombotic/thromboembolic events
    - Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
    - Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous combined oral contraceptive (COC) use
    - Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
    - Severe dyslipoproteinemia
    - Malignant or premalignant disease
    - Uncontrolled thyroid disorder
    - Chronic inflammatory bowel disease

Trial summary

Enrollment Goal
0
Trial Dates
April 2013 - November 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
BEYAZ (EE20/DRSP/L-5-MTHF, BAY98-7071)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Withdrawn
Hospital Sao Lucas da Pontificia Universidade Catolica do RSPorto Alegre, 90619900, Brazil
Withdrawn
Faculdade de Ciencias Medicas-Universidade Estadual CampinasCampinas, 13083-970, Brazil
Withdrawn
Centro de Estudos e Pesquisas em Reproducao Humana e Fertil.Curitiba, 80030-220, Brazil
Withdrawn
Centro de Medicina Reprodutiva Dr. Carlos FilhoPorto Alegre, 90510-040, Brazil
Withdrawn
Universidade Federal de Sao Paulo - UNIFESPSao Paulo, 04039, Brazil
Withdrawn
Gynekos, Centro de Ginecología y Obstetricia.San Luis Potosí, 78230, Mexico
Withdrawn
Hospital Angeles Centro Medico del PotosíSan Luis Potosí, 78200, Mexico
Withdrawn
Hospital Integral de la Mujer del Estado de SonoraHermosillo, 83100, Mexico
Withdrawn
Hospital Nuevo Civil de Guadalajara "Juan I. Menchaca" S.S.Guadalajara, 44340, Mexico
Withdrawn
Centro Inv. Biomédica, Fac. de Medicina de TorreónTorreón, 27000, Mexico
Withdrawn
Investigación Biomédica Aplicada de Hidalgo S.A. de C.V.Pachuca, 42090, Mexico
Withdrawn
Consultorio Mrs. Dr. Navarro VenegasMexico D.F, 06700, Mexico
Withdrawn
Consultorio Dra. Hernández MarínMexico D. F., 03100, Mexico
Withdrawn
Hospital Central UniversitarioChihuahua, 31350, Mexico
Withdrawn
VOX FEMINA – INSTITUTO DE ATENÇÃO À MULHERJUNDIAÍ, Brazil
Withdrawn
Hospital de Clínicas de Porto AlegrePorto Alegre, Brazil
Withdrawn
Hosp Clínicas Facult. Med. de Ribeirão Preto / USPRibeirão Preto, 14055 370, Brazil
Withdrawn
Hospital Leonor Mendes de BarrosSão Paulo, 03015-000, Brazil
Withdrawn
Instituto Mexicano de Investigacion Clinica, SA de CV.Mexico, 06700, Mexico

Primary Outcome

  • Number of bleeding days
    date_rangeTime Frame:
    Approximately 1 year
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Difference in the number of missed tablets between Arms A and B
    date_rangeTime Frame:
    Approximately 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding pattern and cycle control parameters
    date_rangeTime Frame:
    Approximately 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Number of cycles per subject
    date_rangeTime Frame:
    Approximately 1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multicenter, open-label, 3-arm, active-controlled, parallel-group, 1-year study to investigate the efficacy and safety of a flexible regimen of the combined oral contraceptive, with and without 0.451 mg levomefolate calcium (BAY98-7071 and BAY86-5300, respectively) versus the standard 24 + 4 regimen with levomefolate (BAY98-7071 + BAY86-7660) and to assess compliance with a device (CADDY) in healthy women who desire contraception
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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