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

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Mexico, D.F., Distrito Federal, Mexico, CP 14050

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EE20/DRSP/L-5-MTHF	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in RBC folate concentration from baseline to Week 24	Baseline and Week 24
Change in plasma folate concentration from baseline to Week 24	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
RBC folate concentration	Different time points up to 32 weeks
Plasma folate concentration	Different time points up to 32 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (ESTIMATE): July 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Levomefolate calcium; Contraceptives, oral, combined; Neural tube defects
• Other Study ID Numbers: 16484