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Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01331655
First received: April 7, 2011
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  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.


Condition Intervention Phase
Contraception
 Drug: EE20/DRSP (BAY86-5300)
Drug: EE20/DRSP/L-5-MTHF (BAY98-7071)
Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of bleeding days [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in the number of missed tablets between Arms A and B [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Bleeding pattern and cycle control parameters [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Number of cycles per subject [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: EE20/DRSP (BAY86-5300)
Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP (1 tablet/day); up to 120-day treatment period followed by a 4-day tablet-free interval
Experimental: Arm 2 Drug: EE20/DRSP/L-5-MTHF (BAY98-7071)
Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium (1 tablet/day) up to 120-day treatment period followed by a 4-day tablet-free interval
Active Comparator: Arm 3 Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)
Day 1-24: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium per tablet (1 tablet/day) Day 25-28: tablets with 0.451 mg levomefolate calcium (1 tablet/day)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331655

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01331655     History of Changes
Other Study ID Numbers: 14700
Study First Received: April 7, 2011
Last Updated: July 20, 2012
Health Authority: Brazil: National Health Surveillance Agency
Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 19, 2013