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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902264
• Other study ID #: 16484
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2013
• Last updated: April 28, 2016
• Start date: August 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in RBC folate concentration from baseline to Week 24		Baseline and Week 24	No
Primary	Change in plasma folate concentration from baseline to Week 24		Baseline and Week 24	No
Secondary	RBC folate concentration		Different time points up to 32 weeks	No
Secondary	Plasma folate concentration		Different time points up to 32 weeks	No

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