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A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT01359163
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.

Condition or disease Intervention/treatment Phase
Therapeutic Equivalency Drug: etynodiol diacetate Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects
Study Start Date : June 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Femulen commercial tablets Drug: etynodiol diacetate
tablet, 0.5 mg, single dose
Experimental: Femulen reformulated tablets Drug: etynodiol diacetate
tablet, 0.5 mg, single dose



Primary Outcome Measures :
  1. Area under the curve to last time point observed (AUCt) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ]
  2. Highest concentration (Cmax) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ]

Secondary Outcome Measures :
  1. Area under the curve to infinity (AUCinf) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ]
  2. Area under the curve percent to infinity (AUC%inf) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ]
  3. Half-life (T1/2) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ]
  4. Time at maximum concentration (Tmax) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
  • Healthy female subjects between the ages of 21 and 55 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.

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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359163


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01359163     History of Changes
Other Study ID Numbers: B1361002
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by Pfizer:
bioequivalence study
marketed vs reformulation tablets
Femulen

Additional relevant MeSH terms:
Ethynodiol Diacetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs