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Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neural Tube Defects; Contraception; Oral Contraceptives (OC)

Intervention: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate (Drug); Drospirenone/Ethinylestradiol (Yaz) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The purpose of this study is to determine whether the study drug is safe and effective

Clinical Details

Official title: Multi-Center, Randomized, Double-Blind Active-Controlled, Parallel Group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

Red Blood Cell (RBC) Folate Level at 24 Weeks

Plasma Folate Level at 24 Weeks

Secondary outcome:

Mean Neural Tube Defect (NTD) Risk Reduction at Week 24

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16

Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20

Mean Change From Baseline in Plasma Folate Levels at Week 4

Mean Change From Baseline in Plasma Folate Levels at Week 8

Mean Change From Baseline in Plasma Folate Levels at Week 12

Mean Change From Baseline in Plasma Folate Levels at Week 16

Mean Change From Baseline in Plasma Folate Levels at Week 20

Mean Change From Baseline in Plasma Homocysteine Levels at Week 4

Mean Change From Baseline in Plasma Homocysteine Levels at Week 8

Mean Change From Baseline in Plasma Homocysteine Levels at Week 12

Mean Change From Baseline in Plasma Homocysteine Levels at Week 16

Mean Change From Baseline in Plasma Homocysteine Levels at Week 20

Mean Change From Baseline in Plasma Homocysteine Levels at Week 24

Detailed description: Acronym is used in result section: suspected/diagnosed (susp/diag)

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy women between 18 and 40 requesting oral contraception

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter Oral

Contraception metabolism will be prohibited during the study

Locations and Contacts

Orange County Clinical Trials, Anaheim, California 92801, United States

Medical Center for Clinical Research, San Diego, California 92108, United States

SNBL Clinical Pharmacology Center, Inc., Baltimore, Maryland 21201, United States

Columbia University Medical Center, New York, New York 10032, United States

AAIPharma, Inc., Morrisville, North Carolina 27560, United States

Lyndhurst Gynecologic Associates, Winston-Salem, North Carolina 27103, United States

Coastal Carolina Research Center, Mt. Pleasant, South Carolina 29464, United States

New Orleans Center for Clinical Research, Knoxville, Tennessee 37920, United States

NorthWest Kinetics, Tacoma, Washington 98418, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: April 2007
Last updated: April 4, 2014

Page last updated: August 23, 2015

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