HealthyPhase 1NCT01328184

Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

A Phase 1 study testing levonorgestrel, Ethinylestradiol and Microgynon + BI 10773 in people with Healthy, run by Boehringer Ingelheim 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

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Trial summary

The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®). Read more about this study

Who is it for?: Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: levonorgestrel, Ethinylestradiol and Microgynon + BI 10773
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: Apr 2011to Jul 2011
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 39 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1245.41.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Conditions: Healthy
Being tested: levonorgestrel, Ethinylestradiol, Microgynon + BI 10773

What participants receive

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

levonorgestrelDrug
multiple doses
levonorgestrelDrug
multiple doses
EthinylestradiolDrug
multiple doses
Microgynon + BI 10773Drug
multiple doses BI 10773
EthinylestradiolDrug
multiple doses

Study groups in NCT01328184
Study group	Role	What they receive
Reference	Experimental	multiple doses of Microgynon Receives: Drug: levonorgestrel; Drug: Ethinylestradiol
Test	Active comparator	multiple doses of Microgynon + BI 10773 Receives: Drug: levonorgestrel; Drug: Ethinylestradiol; Drug: Microgynon + BI 10773

What is being measured

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

Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)
Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Maximum Measured Concentration (Cmax,ss)
Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Secondary outcomes (14)

Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)
Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)
Apparent clearance of levonorgestrel in the plasma at steady state after oral administration
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
Apparent volume of distribution during the terminal phase at steady state after oral administration
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
Apparent volume of distribution during the terminal phase at steady state after oral administration
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)
Terminal half-life of ethinylestradiol in plasma at steady state
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)
Terminal half-life of levonorgestrel in plasma at steady state
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)
Terminal rate constant of ethinylestradiol in plasma at steady state
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)
Terminal rate constant of levonorgestrel in plasma at steady state
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)
Mean residence time of ethinylestradiol in the body at steady state after oral administration
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)
Mean residence time of levonorgestrel in the body at steady state after oral administration
Measured: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.
Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.
Measured: Day 1 to day 17
Assessment of Tolerability
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.
Measured: Within Day 24 to Day 31

Timeline

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

Apr 2011Jul 2011

First posted4 Apr 2011 (estimated)
Study startApr 2011
Primary completionJul 2011

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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01328184
Sponsor's protocol ID: 1245.41
Other IDs: 2010-023432-16
Status last verified: May 2014
First submitted: 1 Apr 2011
Last updated: 18 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Macha S, Mattheus M, Pinnetti S, Woerle HJ, Broedl UC. Effect of empagliflozin on the steady-state pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female volunteers. Clin Drug Investig. 2013 May;33(5):351-7. doi: 10.1007/s40261-013-0068-y.
PubMed 23512637

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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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers
ClinicalTrials.gov ID: NCT01328184
Acronym / sponsor ID: 1245.41
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jul 2011 (actual)
First posted: 4 Apr 2011 (estimated)
Results: Posted 18 Jun 2014

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reference	Experimental	Drug: levonorgestrel, Drug: Ethinylestradiolmultiple doses of Microgynon
Test	Active comparator	Drug: levonorgestrel, Drug: Ethinylestradiol, Drug: Microgynon + BI 10773multiple doses of Microgynon + BI 10773

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy female subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

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
levonorgestrelmultiple doses	Drug	Reference
levonorgestrelmultiple doses	Drug	Test
Ethinylestradiolmultiple doses	Drug	Test
Microgynon + BI 10773multiple doses BI 10773	Drug	Test
Ethinylestradiolmultiple doses	Drug	Reference

Primary outcome

Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Levonorgestrel: Maximum Measured Concentration (Cmax,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.

14 secondary outcomes

Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)
Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.
Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.
Time frame: Day 1 to day 17
Assessment of Tolerability
Time frame: Within Day 24 to Day 31

Results and safety

Results posted to the registry on 18 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Overall	18	18

Primary outcome: Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.. Geometric mean (Geometric Coefficient of Variation). Unit: pg*h/mL

Measure	Microgynon n = 18	Microgynon Plus Empa n = 18
Value	907 (24.4)	932 (22.8)

Microgynon vs Microgynon Plus Empa: Geometric Mean Ratio: 102.82 (90% CI 97.58 to 108.35), ANOVA

Population analysed: Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.

Primary outcome: Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Measure	Microgynon n = 18	Microgynon Plus Empa n = 18
Value	94.0 (34.4)	95.9 (36.6)

Microgynon vs Microgynon Plus Empa: Geometric Mean Ratio: 101.94 (90% CI 98.54 to 105.47), ANOVA

Primary outcome: Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)

Measure	Microgynon n = 18	Microgynon Plus Empa n = 18
Value	97.6 (17.6)	96.8 (21.8)

Microgynon vs Microgynon Plus Empa: Geometric Mean Ratio: 99.22 (90% CI 93.40 to 105.39), ANOVA

Primary outcome: Levonorgestrel: Maximum Measured Concentration (Cmax,ss)

Measure	Microgynon n = 18	Microgynon Plus Empa n = 18
Value	7.98 (26.1)	8.44 (25.8)

Microgynon vs Microgynon Plus Empa: Geometric Mean Ratio: 105.81 (90% CI 99.47 to 112.55), ANOVA

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: day1 to day17. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microgynon	0 of 18 (0%)	10 of 18 (55.6%)	Not reported
Microgynon Plus Empa	0 of 18 (0%)	10 of 18 (55.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23512637Macha S, Mattheus M, Pinnetti S, Woerle HJ, Broedl UC. Effect of empagliflozin on the steady-state pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female volunteers. Clin Drug Investig. 2013 May;33(5):351-7. doi: 10.1007/s40261-013-0068-y.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing levonorgestrel, Ethinylestradiol and Microgynon + BI 10773 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 18 Jun 2014. 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 18 Jun 2014). 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?

Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) (time frame: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.). The study lists 4 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 NCT01328184, 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 18 Jun 2014.