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Completed

NCT Number: NCT01902264

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

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.

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Key information

Conditions

Contraception Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mexico City, CP 14050, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071)

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2013
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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