Study Completed

Contraception

Bayer Identifier:

16484

ClinicalTrials.gov Identifier:

NCT01902264

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study of treatment with the combination of drospirenone plus ethinyl estradiol plus levomefolate calcium in Mexican women seeking contraception

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

Inclusion Criteria
- Healthy, Mexican female subjects requesting contraception
- Age >/=18 to - 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

Trial summary

Enrollment Goal

Trial Dates

August 2013 - February 2015

Phase

Phase 3

Could I Receive a placebo

Products

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

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Hospital Medica Sur	Mexico, D.F., CP 14050, Mexico

Primary Outcome

Change in RBC folate concentration from baseline to Week 24
Time Frame:
Baseline and Week 24
Safety Issue:
No
Change in plasma folate concentration from baseline to Week 24
Time Frame:
Baseline and Week 24
Safety Issue:
No

Secondary Outcome

RBC folate concentration
Time Frame:
Different time points up to 32 weeks
Safety Issue:
No
Plasma folate concentration
Time Frame:
Different time points up to 32 weeks
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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