Neural Tube DefectsPhase 3NCT00468481

Efficacy and Safety Study for an Oral Contraceptive Containing Folate

A Phase 3 study testing Drospirenone/Ethinylestradiol/Methyltetrahydrofolate and Drospirenone/Ethinylestradiol (Yaz) in people with Neural Tube Defects and Contraception, run by Bayer at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Neural Tube Defects, Contraception, Oral Contraceptives (OC)
What is being tested?: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate and Drospirenone/Ethinylestradiol (Yaz)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 385 participants
Where: 9 sitesUnited States
Study dates: Apr 2007to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy women between 18 and 40 requesting oral contraception

Who cannot join

The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Orange County Clinical Trials
Anaheim, California, 92801
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
AAIPharma, Inc.
Morrisville, North Carolina, 27560
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Columbia University Medical Center
New York, New York, 10032
Medical Center for Clinical Research
San Diego, California, 92108
NorthWest Kinetics
Tacoma, Washington, 98418
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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

Read the detailed description

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

Conditions: Neural Tube Defects, Contraception, Oral Contraceptives (OC)
Being tested: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate, Drospirenone/Ethinylestradiol (Yaz)
Keywords: Healthy women requesting contraception, Folic Acid
Medical subject headings: Neural Tube Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00468481
Study group	Role	What they receive
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)	Experimental	1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks Receives: Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
Drospirenone (DRSP)/Ethinylestradiol (EE)	Active comparator	1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks Receives: Drug: Drospirenone/Ethinylestradiol (Yaz)

What is being measured

The primary outcome is the main question the study is designed to answer.

Red Blood Cell (RBC) Folate Level at 24 Weeks
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Measured: Week 24
Plasma Folate Level at 24 Weeks
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Measured: Week 24

Secondary outcomes (17)

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
Measured: Baseline and week 24
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
Measured: baseline and up to week 4
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
Measured: baseline and up to week 8
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
Measured: baseline and up to week 12
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
Measured: baseline and up to week 16
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
Measured: baseline and up to week 20
Mean Change From Baseline in Plasma Folate Levels at Week 4
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Measured: baseline and up to week 4
Mean Change From Baseline in Plasma Folate Levels at Week 8
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Measured: baseline and up to week 8
Mean Change From Baseline in Plasma Folate Levels at Week 12
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Measured: baseline and up to week 12
Mean Change From Baseline in Plasma Folate Levels at Week 16
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Measured: baseline and up to week 16
Mean Change From Baseline in Plasma Folate Levels at Week 20
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Measured: baseline and up to week 20
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.
Measured: baseline and up to week 4
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.
Measured: baseline and up to week 8
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.
Measured: baseline and up to week 12
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.
Measured: baseline and up to week 16
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.
Measured: baseline and up to week 20
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.
Measured: baseline and up to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Sep 2008

First posted2 May 2007 (estimated)
Study startApr 2007
Primary completionAug 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00468481
Sponsor's protocol ID: 91523
Other IDs: 310662
Status last verified: Apr 2014
First submitted: 30 Apr 2007
Last updated: 23 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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 multicenter study. Contraception. 2012 Jan;85(1):42-50. doi: 10.1016/j.contraception.2011.05.013. Epub 2011 Jul 13.
PubMed 22067790
Castano 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/S1368980013000864. Epub 2013 Mar 27.
PubMed 23534865
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. doi: 10.1016/j.ajog.2011.06.048. Epub 2011 Jun 21.
PubMed 21903192
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 prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.
PubMed 24105751

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Neural Tube Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00468481
Acronym / sponsor ID: 91523
Conditions: Neural Tube Defects, Contraception, Oral Contraceptives (OC)
Keywords: Healthy women requesting contraception, Folic Acid
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 385 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Aug 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 2 May 2007 (estimated)
Results: Posted 25 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)	Experimental	Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
Drospirenone (DRSP)/Ethinylestradiol (EE)	Active comparator	Drug: Drospirenone/Ethinylestradiol (Yaz)1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy women between 18 and 40 requesting oral contraception

Key exclusion criteria (1 listed)

The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drospirenone/Ethinylestradiol/Methyltetrahydrofolate0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)	Drug	Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)
Drospirenone/Ethinylestradiol (Yaz)0.020 mg ethinylestradiol with 3.0 mg drospirenone	Drug	Drospirenone (DRSP)/Ethinylestradiol (EE)

Primary outcome

Red Blood Cell (RBC) Folate Level at 24 Weeks
Time frame: Week 24
RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Plasma Folate Level at 24 Weeks
Time frame: Week 24
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

17 secondary outcomes

Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
Time frame: Baseline and week 24
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4
Time frame: baseline and up to week 4
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8
Time frame: baseline and up to week 8
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12
Time frame: baseline and up to week 12
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16
Time frame: baseline and up to week 16
Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20
Time frame: baseline and up to week 20
Mean Change From Baseline in Plasma Folate Levels at Week 4
Time frame: baseline and up to week 4
Mean Change From Baseline in Plasma Folate Levels at Week 8
Time frame: baseline and up to week 8
Mean Change From Baseline in Plasma Folate Levels at Week 12
Time frame: baseline and up to week 12
Mean Change From Baseline in Plasma Folate Levels at Week 16
Time frame: baseline and up to week 16
Mean Change From Baseline in Plasma Folate Levels at Week 20
Time frame: baseline and up to week 20
Mean Change From Baseline in Plasma Homocysteine Levels at Week 4
Time frame: baseline and up to week 4
Mean Change From Baseline in Plasma Homocysteine Levels at Week 8
Time frame: baseline and up to week 8
Mean Change From Baseline in Plasma Homocysteine Levels at Week 12
Time frame: baseline and up to week 12
Mean Change From Baseline in Plasma Homocysteine Levels at Week 16
Time frame: baseline and up to week 16
Mean Change From Baseline in Plasma Homocysteine Levels at Week 20
Time frame: baseline and up to week 20
Mean Change From Baseline in Plasma Homocysteine Levels at Week 24
Time frame: baseline and up to week 24

Results and safety

Results posted to the registry on 25 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)	291	203
Drospirenone (DRSP)/Ethinylestradiol (EE)	94	70

Primary outcome: Red Blood Cell (RBC) Folate Level at 24 Weeks

Time frame: Week 24. Least squares mean (95% Confidence Interval). Unit: nmol/L

Measure	Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) n = 124	Drospirenone (DRSP)/Ethinylestradiol (EE) n = 45
Value	1406.91 (1354.13 to 1459.68)	1022.21 (934.6 to 1109.82)

Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) vs Drospirenone (DRSP)/Ethinylestradiol (EE): Mean Difference (Final Values): 384.70 (95% CI 282.42 to 486.98), p <0.0001, ANCOVA

Population analysed: Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.

Primary outcome: Plasma Folate Level at 24 Weeks

Time frame: Week 24. Least squares mean (95% Confidence Interval). Unit: nmol/L

Measure	Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) n = 196	Drospirenone (DRSP)/Ethinylestradiol (EE) n = 66
Value	60.55 (58.13 to 62.97)	41.67 (37.50 to 45.85)

Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) vs Drospirenone (DRSP)/Ethinylestradiol (EE): Mean Difference (Final Values): 18.87 (95% CI 14.04 to 23.70), p <0.0001, ANCOVA

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)	3 of 285 (1.1%)	103 of 285 (36.1%)	Not reported
Drospirenone (DRSP)/Ethinylestradiol (EE)	0 of 94 (0%)	44 of 94 (46.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22067790Bart 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 multicenter study. Contraception. 2012 Jan;85(1):42-50. doi: 10.1016/j.contraception.2011.05.013. Epub 2011 Jul 13.
Results publication: PubMed 23534865Castano 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/S1368980013000864. Epub 2013 Mar 27.
Results publication: PubMed 21903192Taylor 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. doi: 10.1016/j.ajog.2011.06.048. Epub 2011 Jun 21.
Results publication: PubMed 24105751Campone 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 prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Red Blood Cell (RBC) Folate Level at 24 Weeks (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00468481, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.