Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharbil Waltrop GmbH
ClinicalTrials.gov Identifier:
NCT01600274
First received: May 8, 2012
Last updated: May 15, 2012
Last verified: May 2012
  Purpose
  • Characterisation of relative bioavailability of Diena (Test) in comparison to Valette® (Reference) after single dose administration under fasting conditions
  • Assessment of bioequivalence of Test vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG)
  • Descriptive characterisation of safety and tolerability of the investigational products in the study population

Condition Intervention
Female
Drug: Ethyinylestradiol Dienogest combination

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Characterisation of Relative Bioavailability and Assessment of Bioequivalence of a Newly Developed Ethinylestradiol/Dienogest IR Formulation in Comparison With a Marketed Reference Product (Valette®)

Resource links provided by NLM:


Further study details as provided by Pharbil Waltrop GmbH:

Primary Outcome Measures:
  • Cmax and AUC0-tlast of EE and DNG after each treatment [ Time Frame: K PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clast, AUCexpol%, AUC0-∞, tmax, t1/2, tlast, λ, MRT, tlag of EE and DNG after each treatment [ Time Frame: K PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ethyinylestradiol Dienogest combination

    A: One tablet of Test B: One tablet of Reference

    2 x 0.03 mg EE = 0.06 mg EE 2 x 2 mg DNG = 4 mg DNG

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. sex: female
  2. ethnic origin: Caucasian
  3. age: 18 - 55 years, inclusive
  4. body-mass index (BMI): more than 19 kg/m² and less than 27 kg/m²
  5. good state of health
  6. non-smoker or an ex-smoker for a least 6 months
  7. written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subject's participating in the study

Exclusion Criteria:

Subjects cannot be included if they match any of the following exclusion criteria:

Safety concerns

  1. existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
  2. existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
  3. existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
  4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  5. pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient
  6. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
  7. subjects with severe allergies or multiple drug allergies
  8. systolic blood pressure > 160 mmHg
  9. diastolic blood pressure > 90 mmHg
  10. heart rate < 45 and > 100 bpm
  11. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
  12. positive anti-HIV-test, HBs-AG-test or anti-HCV-test
  13. presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction and prodromal conditions (e.g. transient ischaemic attack, angina pectoris)), predisposition for venous or arterial thrombosis (e.g. APC-resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency or other thrombogene coagulopathy, heart valve disorders or thrombogene cardiac dysrhythmias)
  14. presence or history of liver tumours or known or suspected sex-hormone influenced malignancies (e.g. of the breasts or endometrium)
  15. unclarified vaginal bleeding or amenorrhoe
  16. subjects with fructose or galactose intolerance, deficiency of lactase, saccharase-isomaltase or malabsortion of glucose/galactose Lack of suitability for the trial
  17. acute or chronic diseases which could affect absorption or metabolism
  18. history of or current drug or alcohol dependence
  19. regular intake of alcoholic food or beverages of ≥ 20 g per day
  20. subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
  21. regular intake of caffeine containing food or beverages of ≥ 500 mg per day
  22. blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject
  23. participation in a clinical trial during the last two months prior to individual enrolment of the subject
  24. regular treatment with any systemically available medication (except usual replacement therapy with L-thyroxine)
  25. subjects, who report a frequent occurrence of migraine attacks
  26. use of hormonal preparations within 6 weeks (oral, transdermal, vaginal), 2 months (intramuscularly administered depot preparations used once per month) or 6 months (intramuscularly administered depot preparations used once per 3 month) before pre-study examination

    For female subjects with childbearing potential only:

  27. positive pregnancy test at pre-study examination
  28. pregnant or lactating women
  29. female subjects who do not agree to apply adequate non-hormonal and highly effective contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000 Administrative reasons
  30. subjects suspected or known not to follow instructions
  31. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study The exclusion criteria are chosen to assure that subjects with specific risks for administration of the investigated medicinal products and subjects with conditions, which may have an impact on pharmacokinetic parameters, cannot be included.
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Pharbil Waltrop GmbH
ClinicalTrials.gov Identifier: NCT01600274     History of Changes
Other Study ID Numbers: 1229ed09ct
Study First Received: May 8, 2012
Last Updated: May 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Ethinyl Estradiol
Dienogest
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014