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Trial record 18 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception

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: NCT01902264
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : April 29, 2016
Information provided by (Responsible Party):

Brief Summary:

The objective of this study is to compare the red blood cell (RBC) and plasma concentrations of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.

Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before and in the first few weeks of pregnancy has been shown to reduce certain types of birth defects. This is important for women who may become pregnant following discontinuation of oral contraception. Information about any side effects that may occur will also be collected.

Condition or disease Intervention/treatment Phase
Contraception Drug: EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Open-label, Single-center Clinical Study to Investigate the Red Blood Cell and Plasma Folate Concentrations During a 24-week Treatment Period With the Combination of Drospirenone 3 mg Plus Ethinyl Estradiol 0.02 mg Plus Levomefolate Calcium 0.451 mg in Mexican Women Seeking Contraception
Study Start Date : August 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: EE20/DRSP/L-5-MTHF Drug: EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071)
One tablet DRSP 3 mg/EE 0.02 mg/ Levomefolate calcium 0.451 mg daily for 24 days, followed by one hormone-free tablet L-5-MTHF 0.451 mg daily for 4 days over 24 weeks

Primary Outcome Measures :
  1. Change in RBC folate concentration from baseline to Week 24 [ Time Frame: Baseline and Week 24 ]
  2. Change in plasma folate concentration from baseline to Week 24 [ Time Frame: Baseline and Week 24 ]

Secondary Outcome Measures :
  1. RBC folate concentration [ Time Frame: Different time points up to 32 weeks ]
  2. Plasma folate concentration [ Time Frame: Different time points up to 32 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy, Mexican female subjects requesting contraception
  • Age >/=18 to </=45 years (inclusive); smokers must not be older than 30 years at the time of informed consent
  • Normal or clinically insignificant cervical smear not requiring further follow-up; a cervical smear has to be taken at the screening visit, or a normal result has to be documented within the previous 6 months. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.

Exclusion Criteria:

  • Pregnancy or lactation (less than 6 months since delivery, abortion, or lactation before start of treatment)
  • Body mass index (BMI) >30 kg/m2
  • Hypersensitivity to any ingredient in the study drug
  • Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
  • Undiagnosed abnormal genital bleeding
  • Abuse of alcohol, drugs or medicine (eg, laxatives)
  • Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug

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): NCT01902264

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Mexico, D.F., Distrito Federal, Mexico, CP 14050
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT01902264     History of Changes
Other Study ID Numbers: 16484
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by Bayer:
Levomefolate calcium
Contraceptives, oral, combined
Neural tube defects
Additional relevant MeSH terms:
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Ethinyl Estradiol
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents
Vitamin B Complex
Growth Substances