- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182207
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
November 22, 2010 updated by: Teva Pharmaceuticals USA
A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Non-Fasting Conditions.
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02
mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02
mg tablets) in healthy, adult subjects under non-fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- PRACS Institute, Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing.
- Subjects who completed the screening process within 28 days prior to Period I dosing.
- Subjects who were healthy, adult, menstruating women 18 to 35 years of age, inclusive, at the time of dosing.
- Subjects with a body mass index (BMI) between 19 and 30 kg/m2, inclusive, and weighed at least 110 pounds.
- Subjects who were healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments, and by general observations. The physical examination also included a gynecological exam. If the subject had completed an acceptable Pap smear and gynecological exam in the previous 12 months (prior to study Day 1) and the documentation of acceptable results were provided, both were deferred. Any abnormalities/deviations from thee normal range which were considered clinically relevant by the study physician and investigator were evaluated for individual cases, documented in study files, and agreed upon by the study physician and investigator prior to enrolling a volunteer in the study and for continued enrollment.
- Female subjects who practice an acceptable non-hormonal method of birth control as judged by the investigator(s) at least 14 days prior to Period I dosing, throughout the study, and until 14 days after Period II dosing. The acceptable non-hormonal birth control methods included: double barriers, non-hormone releasing intrauterine device in place for at least 30 days prior to dosing, abstinence throughout the duration of the study, or surgically sterile for at least 6 months prior to Period I dosing.
Exclusion Criteria:
- Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- Volunteers who reported taking any oral contraceptives including estrogen and progestin combined pills and progestin only pills or patch within 28 days prior to Period I dosing, or using injectable contraceptives within 6 months of Period I dosing.
- Volunteers who have ever had progestational hormone implants.
- Volunteers who reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, liver, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s), or psychiatric or epilepsy disease as determined by the clinical investigator(s).
- Volunteers who reported any presence or history of migraines or severe headaches.
- Volunteers who had a systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 45 or over 90 mmHg were excluded from the study.
- Volunteers who had a history of thrombotic disorders, have ever had a cerebrovascular accident, or had transient ischemic attacks.
- Volunteers with a history of breast cancer or undiagnosed breast nodules, active malignancies, or undiagnosed vaginal bleeding.
- Volunteers having other conditions that may be aggravated by fluid retention (as determined by principle investigator).
- Volunteers who had a history of jaundice with previous use of oral contraceptives or any other kinds of hormonal contraceptives.
- Volunteers whose clinical laboratory test values outside the acceptable range and when confirmed on re-examination were deemed to be clinically significant.
- Volunteers who demonstrated a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Volunteers who reported a history of allergic response(s) to drospirenone/ethinyl estradiol, progestin/estrogens, or related drugs.
- Volunteers who reported the use of any systemic prescription medications in the 14 days prior to Period 1 dosing (with the exception of hormonal contraceptives).
- Volunteers who reported the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Volunteers who reported a history of clinically significant allergies including drug allergies.
- Volunteers who reported a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Volunteers who reported a history of drug or alcohol addiction or abuse within the past year.
- Volunteers who demonstrated a positive drug abuse screen for the study prior to Period I dose administration.
- Volunteers who used tobacco products in the past 6 months.
- Volunteers who reported donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects were advised not to donate blood for 4 weeks after completing the study.
- Volunteers who reported donating plasma within 30 days prior to Period I dosing. All subjects were advised not to donate blood for 4 weeks after completing the study.
- Volunteers who demonstrate a positive pregnancy screen.
- Volunteers who were currently breastfeeding.
- Subjects who had used within the 3 months preceding Period I dosing any vaginally administered estrogen or progestin containing products.
- Any volunteer who engaged in unprotected sexual intercourse during the time interval starting 14 days prior to the first period until 14 days after Period II dosing.
- Volunteers who had a hysterectomy or oophorectomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Investigational Test Product
Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02
mg
|
3 mg/0.02 mg Tablets
Other Names:
|
ACTIVE_COMPARATOR: Reference Listed Drug
YAZ® Tablets, 3 mg/0.02 mg
|
3 mg/0.02 mg Tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)
Time Frame: Blood samples collected over a 120 hour period.
|
Bioequivalence based on Drospirenone Cmax.
|
Blood samples collected over a 120 hour period.
|
AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time Frame: Blood samples collected over a 120 hour period.
|
Bioequivalence based on Drospirenone AUC0-t.
|
Blood samples collected over a 120 hour period.
|
AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time Frame: Blood samples collected over a 120 hour period.
|
Bioequivalence based on Drospirenone AUC0-inf.
|
Blood samples collected over a 120 hour period.
|
Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Time Frame: Blood samples collected over a 72 hour period.
|
Bioequivalence based on Ethinyl Estradiol Cmax.
|
Blood samples collected over a 72 hour period.
|
AUC0-t of Ethinyl 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.
|
Bioequivalence based on Ethinyl Estradiol AUC0-t.
|
Blood samples collected over a 72 hour period.
|
AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time Frame: Blood samples collected over a 72 hour period.
|
Bioequivalence based on Ethinyl Estradiol AUC0-inf.
|
Blood samples collected over a 72 hour period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (ACTUAL)
August 1, 2006
Study Completion (ACTUAL)
August 1, 2006
Study Registration Dates
First Submitted
August 12, 2010
First Submitted That Met QC Criteria
August 13, 2010
First Posted (ESTIMATE)
August 16, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 8, 2010
Last Update Submitted That Met QC Criteria
November 22, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Estradiol
- Ethinyl Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
- Drospirenone
- Drospirenone and ethinyl estradiol combination
Other Study ID Numbers
- R06-0632
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Drospirenone/Ethinyl Estradiol (Gianvi®)
-
Teva Pharmaceuticals USACompletedHealthyUnited States
-
NewAmsterdam PharmaNovumRecruitingHealthy VolunteersUnited States
-
AGUNCO Obstetrics and Gynecology CentreCompleted
-
Bristol-Myers SquibbCompleted
-
Bio-innova Co., LtdNot yet recruiting
-
Ortho-McNeil Janssen Scientific Affairs, LLCCompleted
-
Bio-innova Co., LtdRecruitingHealthy SubjectsThailand
-
Massachusetts General HospitalBayerCompletedDepression | Premenstrual SyndromeUnited States
-
Massachusetts General HospitalBayerCompletedAcne VulgarisUnited States
-
University of North Carolina, Chapel HillFoundation of Hope, North CarolinaTerminatedBinge-Eating Disorder | Bulimia Nervosa | Binge Eating | Eating DisordersUnited States