AzTrials
AzTrials

BioequivalencePhase 1NCT01260805

A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.

A Phase 1 study testing Reference Drug and Test Drug in people with Bioequivalence and Ethinylestradiol, run by Pfizer at 1 site in Brazil.

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

A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets are bioequivalent… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence, Ethinylestradiol, Gestodene
What is being tested?
Reference Drug and Test Drug
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteBrazil
Study dates
Sep 2010to Oct 2010
Phase
Phase 1
Are there results?
None posted in the registry

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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy female subjects in childbearing age, between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • The BMI - Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 10% due to the upper limit (18,5 to 27,39) and total body weight >50kg
  • Do not be a smoker (at least 3 months);
  • Not be using hormone contraceptives for at least 28 days before the medication dosing;
  • Women with a regular menstrual cycle (menstrual cycle that occurs, in average, in each 28 days, varying from 25 to 35 days);
  • Use lubricated condoms with spermicidal or diaphragm with spermicidal (in accordance with the volunteer's preference)
Show all 10Show fewer
  • Systolic Pressure up to 130mmHg;
  • Diastolic Pressure up to 85mmHg;
  • An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • The volunteer has a drug abuse history [subjects using marijuana and hashish will be excluded if they have used these drugs less than three months prior to the medical consult and for drugs such as cocaine, phencyclidine (PCP), crack and heroin, volunteers will be excluded that have used these drugs less than 1 year prior to the medical consult.
  • A positive exam for drugs in urine (Methamphetamine, Opiate, Morphine, Marijuana, Cannabis, Amphetamine, Coccaine, Benzoylecgogine, Benzodiazepine) or a positive test for alcohol before the internment in periods 1 and 2.
  • History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening.
  • The volunteer is a smoker or having stopped smoking less than 3 months
  • The volunteer has participated of any experimental trial or has ingested any experimental drug within the 6 months that precede the beginning of the study (ANVISA: Resolution RDC nº34, from June 3rd 2008).
Show all 14Show fewer
  • 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal medicine, herbal supplements must be discontinued 28 days prior to the first dose of study medication. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication.
  • Implant (ex. Norplant®) or a progesterone depot injection (ex. Depo-Provera®) or the use of any dispositive for the long term treatment with progesterone or estrogens (ex. Estring®) up to 6 months before the administration of the medication in study;
  • A depot injection or an implant of any active ingredient up to 3 months before the administration of the medication in study;
  • Have used an injection contraceptive of Medroxyprogesterone Acetate one year before the beginning of the study;
  • Have had sexual intercourse without a contraceptive method (preservative, IUD, diaphragm with spermicidal) within the last 14 days.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Pfizer Investigational Site

    Aparecida de Goiânia, Goiás, 74935-530

Other trials in Brazil

About this study

Official title: A Phase I, Open Label, Randomized, Two-Way Crossover, Single Dose Study To Determine The Bioequivalence Of Ethinylestradiol + Gestodene - Harmonet 0,02mg + 0,075mg (Laboratórios Pfizer Ltda.) In The Sugar Coated Tablets Form, Versus Femiane® 0,02mg + 0,075mg (Schering Do Brasil Química E Farmacêutica Ltda.), In The Sugar Coated Tablets Form, Under Fasted Conditions In Female And Healthy Volunteers.

A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under fasting conditions.

Read the detailed description

Bioequivalence Study

Being tested
Reference Drug, Test Drug
Keywords
bioequivalence, study, ethinylestradiol, gestodene

What participants receive

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

  • Reference DrugDrug

    Femiane® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose

  • Test DrugDrug

    Harmonet® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose

Study groups in NCT01260805
Study groupRoleWhat they receive
Reference DrugActive comparatorNot described
Receives: Drug: Reference Drug
Test DrugActive comparatorNot described
Receives: Drug: Test Drug

What is being measured

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

  1. Maxium concentration (Cmax) for ethinylestradiol/gestodene in plasma

    Measured: Up to 96h / Up to 144h

  2. Area under the plasma/serum/blood concentration(AUC0-t) time curve from time zero to time t for ethinylestradiol/gestodene

    Measured: Up to 96h / Up to 144h

Secondary outcomes (5)

  1. Area under the curve (AUC0-inf) for ethinylestradiol/gestodene

    Measured: Up to 96h / Up to 144h

  2. Time of maximum concentration (Tmax) for ethinylestradiol/gestodene in plasma

    Measured: Up to 96h / Up to 144h

  3. Elimination of half-life(T1/2) for ethinylestradiol/gestodene

    Measured: Up to 96h / Up to 144h

  4. K el for ethinylestradiol/gestodene

    Measured: Up to 96h / Up to 144h

  5. Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity for ethinylestradiol/gestodene

    Measured: Up to 96h / Up to 144h

Timeline

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

  1. First posted15 Dec 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

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
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01260805
Sponsor's protocol ID
B3341001
Other IDs
ICF PBIO 071/10 APH 100214
Status last verified
Feb 2011
First submitted
14 Dec 2010
Last updated
21 Feb 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Reference Drug and Test Drug in people with Bioequivalence and Ethinylestradiol, run by Pfizer at 1 site in Brazil.

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 10 inclusion and 14 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 21 Feb 2011. 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 Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maxium concentration (Cmax) for ethinylestradiol/gestodene in plasma (time frame: Up to 96h / Up to 144h). 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 NCT01260805.

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 21 Feb 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in