check_circleStudy Completed

Contraception

Bayer Identifier:

91608

ClinicalTrials.gov Identifier:

NCT01083264

EudraCT Number:

2009-011151-52

EU CT Number:

Not Available
Relative bioavailability, transdermally administered EE and GSD, 3 applications sites

Trial purpose

Influence of different application sites on the blood levels after administration of a fertility control patch

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - Healthy female subjects
    - Age 18-45 years
    - Body mass index (BMI) 18-30kg/m²
    - At least 3 months since delivery, abortion, or lactation before the first screening examination
    - Ability to understand and follow study-related instructions
    - Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods
  • - Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
    - Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
    - Regular use of medicines other than contraceptives
    - Smokers (at the age of 31 to 45 years)
    - Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)

Trial summary

Enrollment Goal
43
Trial Dates
October 2009 - May 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany

Primary Outcome

  • AUC(0-168) for EE and Gestodene during week 4 of each treatment period
    date_rangeTime Frame:
    Week 4 of each treatment period ( 3 periods)
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    Safety Issue:
    no

Secondary Outcome

  • Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week
    date_rangeTime Frame:
    Week 1-5 of each treatment period
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    Safety Issue:
    no
  • Adverse Events
    date_rangeTime Frame:
    Week 1-5 of each treatment period
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, randomized, crossover study to investigate the relative bioavailability of transdermally administered ethinylestradiol (EE) and gestodene (GSD) after repeated applications of a fertility control patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene to 3 different application sites (buttocks, arm versus abdomen) in healthy young female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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