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This study has been withdrawn prior to enrollment.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 7, 2013
Last verified: July 2013
  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:


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:
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 7, 2013
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 April 16, 2014