NCT01083264

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

March 8, 2010

Last Update Submit

June 20, 2014

Conditions

Contraception

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

    Week 4 of each treatment period ( 3 periods)

Secondary Outcomes (2)

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

    Week 1-5 of each treatment period

  • Adverse Events

    Week 1-5 of each treatment period

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Gestodene/EE Patch (BAY86-5016)

Arm 2

EXPERIMENTAL
Drug: Gestodene/EE Patch (BAY86-5016)

Arm 3

EXPERIMENTAL
Drug: Gestodene/EE Patch (BAY86-5016)

Interventions

Gestodene/EE Patch (BAY86-5016)DRUG

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

Arm 1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 9, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

DE(1)