Status:
COMPLETED
Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01902264
Start Date
August 1 2013
End Date
February 1 2015
Last Update
April 29 2016
Active Locations (1)
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1
Mexico City, Mexico City, Mexico, CP 14050