Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468481
• Other study ID #: 91523
• Secondary ID: 310662
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2007
• Last updated: April 4, 2014
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Contraception
• Neural Tube Defects
• Oral Contraceptives (OC)
• Spinal Dysraphism

Intervention

Drug:
• Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
• Drospirenone/Ethinylestradiol (Yaz)
0.020 mg ethinylestradiol with 3.0 mg drospirenone

Locations

Country	Name	City	State
United States	Orange County Clinical Trials	Anaheim	California
United States	SNBL Clinical Pharmacology Center, Inc.	Baltimore	Maryland
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	AAIPharma, Inc.	Morrisville	North Carolina
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Columbia University Medical Center	New York	New York
United States	Medical Center for Clinical Research	San Diego	California
United States	NorthWest Kinetics	Tacoma	Washington
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bart S Sr, Marr J, Diefenbach K, Trummer D, Sampson-Landers C. Folate status and homocysteine levels during a 24-week oral administration of a folate-containing oral contraceptive: a randomized, double-blind, active-controlled, parallel-group, US-based mu — View Citation

Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the pr — View Citation

Castaño PM, Aydemir A, Sampson-Landers C, Lynen R. The folate status of reproductive-aged women in a randomised trial of a folate-fortified oral contraceptive: dietary and blood assessments. Public Health Nutr. 2014 Jun;17(6):1375-83. doi: 10.1017/S136898 — View Citation

Taylor TN, Farkouh RA, Graham JB, Colligs A, Lindemann M, Lynen R, Candrilli SD. Potential reduction in neural tube defects associated with use of Metafolin-fortified oral contraceptives in the United States. Am J Obstet Gynecol. 2011 Nov;205(5):460.e1-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red Blood Cell (RBC) Folate Level at 24 Weeks	RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit	Week 24	No
Primary	Plasma Folate Level at 24 Weeks	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.	Week 24	No
Secondary	Mean Neural Tube Defect (NTD) Risk Reduction at Week 24	The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline	Baseline and week 24	No
Secondary	Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4	RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit	baseline and up to week 4	No
Secondary	Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8	RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit	baseline and up to week 8	No
Secondary	Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12	RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit	baseline and up to week 12	No
Secondary	Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16	RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit	baseline and up to week 16	No
Secondary	Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20	RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit	baseline and up to week 20	No
Secondary	Mean Change From Baseline in Plasma Folate Levels at Week 4	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.	baseline and up to week 4	No
Secondary	Mean Change From Baseline in Plasma Folate Levels at Week 8	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.	baseline and up to week 8	No
Secondary	Mean Change From Baseline in Plasma Folate Levels at Week 12	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.	baseline and up to week 12	No
Secondary	Mean Change From Baseline in Plasma Folate Levels at Week 16	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.	baseline and up to week 16	No
Secondary	Mean Change From Baseline in Plasma Folate Levels at Week 20	Folate concentrations in plasma were determined by an appropriately validated microbiological assay.	baseline and up to week 20	No
Secondary	Mean Change From Baseline in Plasma Homocysteine Levels at Week 4	Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.	baseline and up to week 4	No
Secondary	Mean Change From Baseline in Plasma Homocysteine Levels at Week 8	Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.	baseline and up to week 8	No
Secondary	Mean Change From Baseline in Plasma Homocysteine Levels at Week 12	Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.	baseline and up to week 12	No
Secondary	Mean Change From Baseline in Plasma Homocysteine Levels at Week 16	Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.	baseline and up to week 16	No
Secondary	Mean Change From Baseline in Plasma Homocysteine Levels at Week 20	Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.	baseline and up to week 20	No
Secondary	Mean Change From Baseline in Plasma Homocysteine Levels at Week 24	Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.	baseline and up to week 24	No

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