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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01902264
First received: July 15, 2013
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in RBC folate concentration from baseline to Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change in plasma folate concentration from baseline to Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RBC folate concentration [ Time Frame: Different time points up to 32 weeks ] [ Designated as safety issue: No ]
  • Plasma folate concentration [ Time Frame: Different time points up to 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902264

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01902264     History of Changes
Other Study ID Numbers: 16484
Study First Received: July 15, 2013
Last Updated: August 21, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Bayer:
Levomefolate calcium
Contraceptives, oral, combined
Neural tube defects

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
Drospirenone
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014