HealthyPhase 1NCT01157182

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions

A Phase 1 study testing Estradiol/Norethindrone acetate and Activella® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

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 objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting… Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Estradiol/Norethindrone acetate and Activella®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteCanada
Study dates: Feb 2007to Apr 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 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Non-smoking or smoking (up to 10 cigarettes/day), physiologically or surgically post-menopausal female within the age range of 18-65 years.
17β-estradiol serum levels of < 90 pmol/L and follicle-stimulating hormone (FSH) of > 40 IU/L.
Body Mass Index greater than or equal to 19.0 and less than or equal to 32.0.
Normal findings in the physical examination, 12-lead electrocardiogram (ECG) and vital signs.
Hemoglobin > 115 g/L
Normal Pap smear within 6 months.

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Normal mammogram within 1 year for subjects who are over the age of 50 years.
Negative for drugs of abuse and alcohol.
Negative for hepatitis B surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV).
No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator or Sub-investigator decides that they are not clinically significant.
Negative for pregnancy.
Subjects who are surgically post-menopausal with an intact uterus (i.e. bilateral oophorectomy) for at least 6 months, or physiologically post-menopausal (i.e. spontaneous amenorrhea) for at least 1 year, and who will adhere to contraceptive requirements from at least 10 days before Period I check in, during the study and up to 1 month after the end of the study.
Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidence by a signed ICF.

Who cannot join

Known history of hypersensitivity to norethindrone and estradiol combinations and/or norethindrone, and/or estradiol.
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, or hematological diseases, malignancies, or migraines, unless deemed NCS by the Principal Investigator or Sub-investigator.
Known history of liver, kidney, and/or gallbladder dysfunction/disease, chronic diarrhea or inflammatory bowel disease.
Known history or presence of cerebrovascular diseases or venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Any history of stroke.
Presence of any significant physical or organ abnormality.

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History of osteoporosis.
History or presence of fibrocystic breast disease.
History or presence of breast, endometrial, cervical, and/or uterine carcinoma.
Any illness during the 4 weeks before the study, unless deemed NCS by the Principal Investigator or Sub-investigator.
Any history or evidence of psychiatric or psychological disease, unless deemed NCS by the Principal Investigator or Sub-investigator.
Any history of abnormal vaginal bleeding, unless deemed NCS by the Principal Investigator or Sub-investigator.
Any history of asthma (after 12 years of age).
Evidence of pregnancy or lactation.
Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any history of drug abuse.
Any recent history of alcohol abuse (less than 1 year).
Use of any prescription medication within 30 days preceding this study.
Use of hormone replacement therapy within 30 days before drug administration.
Use of over-the-counter medication or any herbal supplement within the 7 days preceding this study (except for spermicidal/barrier contraceptive products).
Use of hormonal contraceptives within the 30 days before drug administration or a depot injection of progestogen drug within 1 year before drug administration.
Depot injection of any drug (other than progestogen) within 6 months.
Blood draws within 56 days preceding this study, during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
Blood donations within 56 days preceding this study.
Participation as a plasma donor in a plasmapheresis program within 7 days preceding this study.
Participation in a clinical trial with an investigational drug within 30 days preceding this study.
Intolerance to venipuncture.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Biovail Clinical Research
Toronto, Ontario, M1L 4S4

Other trials in Canada

About this study

Official title: A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions: Healthy
Being tested: Estradiol/Norethindrone acetate, Activella®
Keywords: Healthy, Bioequivalence, Post-Menopausal

What participants receive

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

Estradiol/Norethindrone acetateDrug
Also called Mimvey®
1/0.5 mg Tablets
Activella®Drug
Also called Estradiol/Norethindrone acetate (generic name)
1/0.5 mg Tablets

Study groups in NCT01157182
Study group	Role	What they receive
Investigational Test Product	Experimental	Estradiol/Norethindrone acetate 1/0.5 mg Tablets Receives: Drug: Estradiol/Norethindrone acetate
Reference Listed Drug	Active comparator	Activella® 1/0.5 mg Tablets Receives: Drug: Activella®

What is being measured

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

Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Norethindrone Cmax.
Measured: Blood samples collected over a 36 hour period.
AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Norethindrone AUC0-t.
Measured: Blood samples collected over a 36 hour period.
AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Norethindrone AUC0-inf.
Measured: Blood samples collected over a 36 hour period.
Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Corrected Total Estrone Cmax.
Measured: Blood samples collected over a 72 hour period.
AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Corrected Total Estrone AUC0-t.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Corrected Total Estrone AUC0-inf.
Measured: Blood samples collected over a 72 hour period.

Secondary outcomes (15)

Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for Uncorrected Total Estrone.
Measured: Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for Uncorrected Total Estrone.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for Uncorrected Total Estrone.
Measured: Blood samples collected over a 72 hour period.
Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.
Measured: Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.
Measured: Blood samples collected over a 72 hour period.
Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.
Measured: Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.
Measured: Blood samples collected over a 72 hour period.
Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for Corrected Unconjugated Estradiol.
Measured: Blood samples collected over a 72 hour period.
AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.
Measured: Blood samples collected over a 72 hour period.
Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for Corrected Unconjugated Estrone.
Measured: Blood samples collected over a 72 hour period.
AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.
Measured: Blood samples collected over a 72 hour period.

Timeline

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

Feb 2007Apr 2007

First posted5 Jul 2010 (estimated)
Study startFeb 2007
Primary completionApr 2007
Study completionApr 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.
Other trials for HealthyStudies of the same condition, open and under way.
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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01157182
Sponsor's protocol ID: 3251
Status last verified: Nov 2010
First submitted: 2 Jul 2010
Last updated: 17 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects
ClinicalTrials.gov ID: NCT01157182
Acronym / sponsor ID: 3251
Conditions: Healthy
Keywords: Healthy, Bioequivalence, Post-Menopausal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 5 Jul 2010 (estimated)
Results: Posted 17 Dec 2010

Clinical summary

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

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: Estradiol/Norethindrone acetateEstradiol/Norethindrone acetate 1/0.5 mg Tablets
Reference Listed Drug	Active comparator	Drug: Activella®Activella® 1/0.5 mg Tablets

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Non-smoking or smoking (up to 10 cigarettes/day), physiologically or surgically post-menopausal female within the age range of 18-65 years.
17β-estradiol serum levels of < 90 pmol/L and follicle-stimulating hormone (FSH) of > 40 IU/L.
Body Mass Index greater than or equal to 19.0 and less than or equal to 32.0.
Normal findings in the physical examination, 12-lead electrocardiogram (ECG) and vital signs.
Hemoglobin > 115 g/L

Key exclusion criteria (28 listed)

Known history of hypersensitivity to norethindrone and estradiol combinations and/or norethindrone, and/or estradiol.
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, or hematological diseases, malignancies, or migraines, unless deemed NCS by the Principal Investigator or Sub-investigator.
Known history of liver, kidney, and/or gallbladder dysfunction/disease, chronic diarrhea or inflammatory bowel disease.
Known history or presence of cerebrovascular diseases or venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Any history of stroke.

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
Estradiol/Norethindrone acetateAlso: Mimvey®1/0.5 mg Tablets	Drug	Investigational Test Product
Activella®Also: Estradiol/Norethindrone acetate (generic name)1/0.5 mg Tablets	Drug	Reference Listed Drug

Primary outcome

Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Norethindrone Cmax.
AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Norethindrone AUC0-t.
AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Norethindrone AUC0-inf.
Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Corrected Total Estrone Cmax.
AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Corrected Total Estrone AUC0-t.
AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Corrected Total Estrone AUC0-inf.

15 secondary outcomes

Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.

Results and safety

Results posted to the registry on 17 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estradiol/Norethindrone Acetate (Test) First	18	18
Activella® (Reference) First	18	18

Primary outcome: Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 36 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Estradiol/Norethindrone Acetate (Test) n = 34	Activella® (Reference) n = 34
Value	10.08 (3.32)	9.90 (3.68)

Estradiol/Norethindrone Acetate (Test) vs Activella® (Reference): Ratio of the T/R geometric mean x 100: 102.94 (90% CI 97.63 to 108.55)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Time frame: Blood samples collected over a 36 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Estradiol/Norethindrone Acetate (Test) n = 34	Activella® (Reference) n = 34
Value	36.59 (19.54)	37.05 (18.07)

Estradiol/Norethindrone Acetate (Test) vs Activella® (Reference): Ratio of the T/R geometric mean x 100: 98.40 (90% CI 95.15 to 101.76)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 36 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Estradiol/Norethindrone Acetate (Test) n = 34	Activella® (Reference) n = 34
Value	39.94 (20.14)	40.40 (18.90)

Estradiol/Norethindrone Acetate (Test) vs Activella® (Reference): Ratio of the T/R geometric mean x 100: 98.73 (90% CI 95.33 to 102.26)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 72 hour period.. Mean (Standard Deviation). Unit: pg/mL

Measure	Estradiol/Norethindrone Acetate (Test) n = 34	Activella® (Reference) n = 34
Value	43997.17 (10387.84)	47015.47 (9894.22)

Estradiol/Norethindrone Acetate (Test) vs Activella® (Reference): Ratio of the T/R geometric mean x 100: 92.51 (90% CI 88.64 to 96.55)

Population analysed: All participants that completed the study had their samples analyzed.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estradiol/Norethindrone Acetate (Test) First	0 of 36 (0%)	3 of 36 (8.3%)	Not reported
Activella® (Reference) First	0 of 36 (0%)	0 of 36 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Paul Y Tam, M.D., F.R.C.P., F.A.C.P. principal investigator

Biovail Contract Research

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 Estradiol/Norethindrone acetate and Activella® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

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 13 inclusion and 28 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 17 Dec 2010. 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 Canada. 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 17 Dec 2010). 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?

Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 36 hour period.). The study lists 6 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 NCT01157182.

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 17 Dec 2010.