NCT00318799

Brief Summary

The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

April 26, 2006

Last Update Submit

November 20, 2013

Conditions

Pregnancy, Unplanned

Keywords

prevention of unintended pregnancies

Outcome Measures

Primary Outcomes (1)

  • Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover

    Baseline, Cycle 3 of each treatment period

Secondary Outcomes (2)

  • Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).

    Baseline, Cycle 3 of each treatment period

  • Adverse events

    2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Arm 2

ACTIVE COMPARATOR
Drug: SH D01155E

Interventions

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)DRUG

per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo

Arm 1
SH D01155EDRUG

per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Arm 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy female volunteers

You may not qualify if:

  • Pregnancy or lactation
  • Any condition that might interfere with the outcome as all contraindications for OC use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dinox B.V.

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Drugs R D. 2011;11(2):159-70. doi: 10.2165/11591200-000000000-00000.

    PMID: 21679006RESULT

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

April 26, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

NL(1)