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CompletedNCT01083264Updated Jun 23, 2014

Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

A Phase 1 interventional study of Gestodene/EE Patch (BAY86-5016) and Gestodene/EE Patch (BAY86-5016) in Contraception, sponsored by Bayer. Completed at 1 site in Germany. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-06-23.

Sponsored by Bayer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Contraception

Keywords

  • Pharmacokinetics
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Gestodene/EE Patch (BAY86-5016)

  • Experimental
    Arm 2

    Drug: Gestodene/EE Patch (BAY86-5016)

  • Experimental
    Arm 3

    Drug: Gestodene/EE Patch (BAY86-5016)

Interventions

  • DrugGestodene/EE Patch (BAY86-5016)

    Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks

  • DrugGestodene/EE Patch (BAY86-5016)

    Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm

  • DrugGestodene/EE Patch (BAY86-5016)

    Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen

06

What researchers measure

Primary outcomes

  1. AUC(0-168) for EE and Gestodene during week 4 of each treatment period

    Time frame: Week 4 of each treatment period ( 3 periods)

Secondary outcomes

  1. Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week

    Time frame: Week 1-5 of each treatment period

  2. Adverse Events

    Time frame: Week 1-5 of each treatment period

07

Study locations

1 site
  • Berlin, 13353, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01083264
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 9, 2010
Start date
Oct 2009
Primary completion
May 2010
Completion
May 2010
Last update
Jun 23, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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