NCT00933179

Brief Summary

The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism 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
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

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

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

July 3, 2009

Last Update Submit

November 13, 2014

Conditions

Contraception

Keywords

Prevention of pregnancy

Outcome Measures

Primary Outcomes (1)

  • Prothrombin fragment 1+2, D-dimer

    Screening, visit 3-7

Secondary Outcomes (3)

  • Procoagulatory parameters

    Screening, visit 3-7

  • Anticoagulatory parameters

    Screening, visit 3-7

  • Thrombin and Fibrin turnover parameters

    Screening, visit 3-7

Study Arms (2)

Arm 1

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

Arm 2

ACTIVE COMPARATOR
Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)

Interventions

Gestodene/EE Patch (BAY86-5016)DRUG

21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles

Arm 1
EE/Levonorgestrel (Microgynon, BAY86-4977)DRUG

21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Healthy woman requesting contraception
  • Normal cervical smear not requiring further follow-up
  • History of regular cyclic menstrual periods
  • Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

You may not qualify if:

  • Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2)
  • Any diseases or conditions that can compromise the function of the body systems
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment
  • Undiagnosed abnormal genital bleeding
  • Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Related Publications (1)

  • Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.

    PMID: 24043457RESULT

Related Links

MeSH Terms

Interventions

ethinyl estradiol, levonorgestrel drug combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 7, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

DE(1)