Study of Treatment With the Combination of Drospirenone P... | NCT01902264

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

NCT01902264

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 29, 2016Estimated

Enrollment

34Actual

Phase

Phase 3

Conditions

Contraception

Interventions

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

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jul 15, 2013

First Submission Date that Met QC Criteria

Jul 15, 2013

First Posted Date

Jul 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2016

Last Update Posted Date

Apr 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EE20/DRSP/L-5-MTHF	Experimental		Drug: EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Mexico City	Mexico City	CP 14050	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D009436	Neural Tube Defects

Ancestor Terms

ID	Term
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided