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

Last updated on May 9, 2018

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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Similar Trials

Bioequivalence, Ethinylestradiol, Gestodene, Harmonet
NCT01260805
Females
18+
Years
Aparecida de Goiania, GO
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
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.
Bioequivalence Study
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Bioequivalence
  • Ethinylestradiol
  • Gestodene
  • Harmonet
  • 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
  • Active Comparator: Reference Drug
    Intervention: Drug: Reference Drug
  • Active Comparator: Test Drug
    Intervention: Drug: Test Drug
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01260805
B3341001
ICF PBIO 071/10 APH 100214
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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