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

Bayer

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01902264

16484

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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