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

Last updated on December 7, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aparecida de Goiania, GO, 74935-530 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bioequivalence, Ethinylestradiol, Gestodene, Harmonet
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

- 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.

NCT01260805
Pfizer
Completed
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.

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Descriptive Information
Brief Title  ICMJE A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
Official Title  ICMJE 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.
Brief SummaryA 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.
Detailed DescriptionBioequivalence Study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Bioequivalence
  • Ethinylestradiol
  • Gestodene
  • Harmonet
Intervention  ICMJE
  • Drug: Reference Drug
    Femiane® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose
  • Drug: Test Drug
    Harmonet® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose
Study Arms  ICMJE
  • Active Comparator: Reference Drug
    Intervention: Drug: Reference Drug
  • Active Comparator: Test Drug
    Intervention: Drug: Test Drug
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 14, 2010)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion DateOctober 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01260805
Other Study ID Numbers  ICMJE B3341001
ICF PBIO 071/10 APH 100214
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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