NCT00896571

Brief Summary

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

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

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

May 8, 2009

Last Update Submit

November 24, 2014

Conditions

Contraception

Keywords

Fertility controlContraception

Outcome Measures

Primary Outcomes (1)

  • Effect on the endometrium at cycle 13

    13 treatment cycles (each consisting of 28 days)

Secondary Outcomes (5)

  • Cervical smear

    13 treatment cycles (each consisting of 28 days)

  • Adverse events

    13 treatment cycles (each consisting of 28 days)

  • Cycle control

    13 treatment cycles (each consisting of 28 days)

  • Safety laboratory

    13 treatment cycles (each consisting of 28 days)

  • Occurence of pregnancy

    13 treatment cycles (each consisting of 28 days)

Other Outcomes (2)

  • Treatment compliance

    13 treatment cycles (each consisting of 28 days)

  • Subjective assessment of satisfaction with the treatment

    13 treatment cycles (each consisting of 28 days)

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Ethinylestradiol/Gestogene (BAY86-5016)

Interventions

Ethinylestradiol/Gestogene (BAY86-5016)DRUG

7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Arm 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Requiring contraception
  • Normal cervical smear
  • Smokers not older than 30 years
  • History of regular cyclic menstrual periods

You may not qualify if:

  • Pregnancy or lactation
  • Obesity (BMI\> 30 kg/m2)
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 10629, Germany

Location

Related Links

MeSH Terms

Interventions

Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

DE(1)