ContraceptionPhase 1NCT01253174

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)

A Phase 1 study testing EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131), EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) and L-5-MTHF Ca 0.451 mg (Metafolin) in people with Contraception, run by Bayer at 1 site in Germany.

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 examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without Yasmin… Read more about this study

Who is it for?: Ages 18 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131), EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) and L-5-MTHF Ca 0.451 mg (Metafolin)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: Aug 2006to Jul 2007
Phase: Phase 1
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 38 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female volunteer
Age: 18 - 38 years inclusive
Body mass index (BMI)1: ≥ 19 and < 28 kg/m²
Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation

Who cannot join

incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
known or suspected sex-steroid influenced malignancies
endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
known or suspected tumors of the liver and pituitary
presence or history of severe hepatic disease as long as liver function values have not returned to normal
severe renal insufficiency or acute renal failure

Show all 12Show fewer

thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of prodromi of a thrombosis
other conditions that increase susceptibility to thromboembolic diseases
known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or deficient status of folate or vitamin B12
use of any other medication within 2 cycles before first study drug administration which could affect the study aim
use of potassium sparing drugs; use of folic acid containing supplements or medicines or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism
inadequate folate and/or Vitamin B12 status , clinically relevant deviations in red cell folate concentrations

Trial locations and contacts

1 site in 1 country.

Germany1 site

Scope International
Hamburg, Free and Hanseatic City of Hamburg, 22525

Other trials in Germany

About this study

Official title: Open-label, Randomized, Three-fold Crossover Study to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.03 mg Ethinylestradiol (EE) and 3 mg Drospirenone (DRSP) Without [SH T470FA] and With [SH T04532A] 0.451 mg Metafolin®, and to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.451 mg Metafolin® Without [SH T04532C] and With 0.03 mg EE/ 3 mg DRSP [SH T04532A] in 42 Healthy Young Women

Conditions: Contraception
Being tested: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131), EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca), L-5-MTHF Ca 0.451 mg (Metafolin)

What participants receive

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

EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)Drug
single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)Drug
single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin
L-5-MTHF Ca 0.451 mg (Metafolin)Drug
single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin

Study groups in NCT01253174
Study group	Role	What they receive
EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)	Experimental	single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) Receives: Drug: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)
EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)	Experimental	single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) Receives: Drug: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)
L-5-MTHF Ca 0.451 mg (Metafolin)	Active comparator	single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) Receives: Drug: L-5-MTHF Ca 0.451 mg (Metafolin)

What is being measured

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

Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: up to 96 hours after administration
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Measured: up to 96 hours after administration
Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: up to 168 hours after administration
Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Measured: up to 168 hours after administration
Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation
The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
Measured: up to 12 hours after administration
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation
The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
Measured: up to 12 hours after administration
Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation
The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
Measured: up to 12 hours after administration
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation
The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
Measured: up to 12 hours after administration

Secondary outcomes (4)

Time to Reach Maximum Concentration (Tmax) of EE
Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content
Measured: up to 96 hours after administration
Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Measured: up to 72 hours after administration
Time to Reach Maximum Concentration (Tmax) of DRSP
Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content
Measured: up to 168 hours after administration
Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF
Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content
Measured: up to 12 hours after administration

Timeline

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

Aug 2006Jul 2007

First posted3 Dec 2010 (estimated)
Study startAug 2006
Primary completionJul 2007
Study completionJul 2007

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 (1)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253174
Sponsor's protocol ID: 91457
Other IDs: 2005-001913-16, 2005
Status last verified: Aug 2013
First submitted: 2 Dec 2010
Last updated: 7 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wiesinger H, Eydeler U, Richard F, Trummer D, Blode H, Rohde B, Diefenbach K. Bioequivalence evaluation of a folate-supplemented oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium versus ethinylestradiol/drospirenone and levomefolate calcium alone. Clin Drug Investig. 2012 Oct 1;32(10):673-84. doi: 10.1007/BF03261921.
PubMed 22909145

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?

See locations

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All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Randomized, Three-fold Crossover Study to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.03 mg Ethinylestradiol (EE) and 3 mg Drospirenone (DRSP) Without [SH T470FA] and With [SH T04532A] 0.451 mg Metafolin®, and to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.451 mg Metafolin® Without [SH T04532C] and With 0.03 mg EE/ 3 mg DRSP [SH T04532A] in 42 Healthy Young Women
ClinicalTrials.gov ID: NCT01253174
Acronym / sponsor ID: 91457
Conditions: Contraception
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 9 May 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)	Experimental	Drug: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)	Experimental	Drug: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
L-5-MTHF Ca 0.451 mg (Metafolin)	Active comparator	Drug: L-5-MTHF Ca 0.451 mg (Metafolin)single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])

Who may qualify

Ages: 18 to 38 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy female volunteer
Age: 18 - 38 years inclusive
Body mass index (BMI)1: ≥ 19 and < 28 kg/m²
Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation

Key exclusion criteria (12 listed)

incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
known or suspected sex-steroid influenced malignancies
endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
known or suspected tumors of the liver and pituitary
presence or history of severe hepatic disease as long as liver function values have not returned to normal

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
EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)	Drug	EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)
EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin	Drug	EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)
L-5-MTHF Ca 0.451 mg (Metafolin)single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin	Drug	L-5-MTHF Ca 0.451 mg (Metafolin)

Primary outcome

Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation
Time frame: up to 96 hours after administration
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation
Time frame: up to 96 hours after administration
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation
Time frame: up to 168 hours after administration
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation
Time frame: up to 168 hours after administration
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation
Time frame: up to 12 hours after administration
The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation
Time frame: up to 12 hours after administration
The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation
Time frame: up to 12 hours after administration
The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation
Time frame: up to 12 hours after administration
The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.

4 secondary outcomes

Time to Reach Maximum Concentration (Tmax) of EE
Time frame: up to 96 hours after administration
Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP
Time frame: up to 72 hours after administration
Time to Reach Maximum Concentration (Tmax) of DRSP
Time frame: up to 168 hours after administration
Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF
Time frame: up to 12 hours after administration

Results and safety

Results posted to the registry on 9 May 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
Treatment Sequence A: Yasmin, EE30/DRSP/L-5-MTHF Ca, Metafolin	6	6
Treatment Sequence B: Yasmin, Metafolin, EE30/DRSP/L-5-MTHF Ca	10	9
Treatment Sequence C: EE30/DRSP/L-5-MTHF Ca, Yasmin, Metafolin	9	8
Treatment Sequence D: EE30/DRSP/L-5-MTHF Ca, Metafolin, Yasmin	7	7
Treatment Sequence E: Metafolin, Yasmin, EE30/DRSP/L-5-MTHF Ca	9	8
Treatment Sequence F: Metafolin, EE30/DRSP/L-5-MTHF Ca, Yasmin	7	7

Primary outcome: Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation

Time frame: up to 96 hours after administration. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) n = 42	EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) n = 42
Value	58.5 (53.1 to 64.4)	61.6 (56.6 to 67.0)

EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) vs EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca): mean ratio: 102.26 (90% CI 96.65 to 108.20), ANOVA

Population analysed: Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.

Primary outcome: Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation

Time frame: up to 96 hours after administration. Geometric mean (95% Confidence Interval). Unit: pg∙h/mL

Measure	EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) n = 42	EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) n = 42
Value	573 (521 to 632)	595 (544 to 651)

EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) vs EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca): mean ratio: 101.13 (90% CI 97.65 to 104.75), ANOVA

Population analysed: Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.

Primary outcome: Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation

Time frame: up to 168 hours after administration. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) n = 40	EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) n = 40
Value	26.3 (23.9 to 28.9)	27.2 (25.3 to 29.2)

EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) vs EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca): mean ratio: 98.66 (90% CI 93.37 to 104.24), ANOVA

Population analysed: Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.

Primary outcome: Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation

Time frame: up to 168 hours after administration. Geometric mean (95% Confidence Interval). Unit: ng∙h/mL

Measure	EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) n = 40	EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) n = 40
Value	433 (397 to 473)	447 (417 to 479)

EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) vs EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca): mean ratio: 99.45 (90% CI 96.70 to 102.28), ANOVA

Population analysed: Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)	0 of 44 (0%)	27 of 44 (61.4%)	Not reported
EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)	0 of 43 (0%)	31 of 43 (72.1%)	Not reported
L-5-MTHF Ca 0.451mg (Metafolin)	0 of 43 (0%)	16 of 43 (37.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22909145Wiesinger H, Eydeler U, Richard F, Trummer D, Blode H, Rohde B, Diefenbach K. Bioequivalence evaluation of a folate-supplemented oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium versus ethinylestradiol/drospirenone and levomefolate calcium alone. Clin Drug Investig. 2012 Oct 1;32(10):673-84. doi: 10.1007/BF03261921.

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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

1 site 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 5 inclusion and 12 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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 9 May 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?

Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation (time frame: up to 96 hours after administration). The study lists 8 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 NCT01253174, which also lists 1 linked publication.

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 7 Aug 2013.