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

NCT01902264 | Completed Phase 3

• 1 other identifier: 16484
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Levomefolate calcium; Contraceptives, oral, combined; Neural tube defects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• RBC folate concentration

  Different time points up to 32 weeks

• Plasma folate concentration

  Different time points up to 32 weeks

Study Arms (1)

EE20/DRSP/L-5-MTHF

EXPERIMENTAL

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

Interventions

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

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

EE20/DRSP/L-5-MTHF

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Mexico City, Mexico City, CP 14050, Mexico

Location

MeSH Terms

Conditions

Neural Tube Defects

Interventions

beyaz

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2016-04

Locations

ME (1)