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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01331655
Recruitment Status : Withdrawn
First Posted : April 8, 2011
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Number of bleeding days [ Time Frame: Approximately 1 year ]

Secondary Outcome Measures :
  1. Difference in the number of missed tablets between Arms A and B [ Time Frame: Approximately 1 year ]
  2. Bleeding pattern and cycle control parameters [ Time Frame: Approximately 1 year ]
  3. Number of cycles per subject [ Time Frame: Approximately 1 year ]

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01331655

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01331655     History of Changes
Other Study ID Numbers: 14700
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents
Vitamin B Complex
Growth Substances