Clinical trial NCT01902264: Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Levomefolate calcium
Contraceptives, oral, combined
Neural tube defects
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in RBC folate concentration from baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in plasma folate concentration from baseline to Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: RBC folate concentration
timeFrame: Different time points up to 32 weeks
measure: Plasma folate concentration
timeFrame: Different time points up to 32 weeks
Other outcomes:
Locations:
city: Mexico, D.F.
country: Mexico
state: Distrito Federal
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: