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

NCT ID: NCT01902264

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-02-28

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

EE20/DRSP/L-5-MTHF

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

16484

Identifier Type: -

Identifier Source: org_study_id