Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00318799

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Unplanned	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) Drug: SH D01155E	Phase 2

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Single-centre, Open-label, Crossover, Controlled, Randomized Study to Investigate the Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters in 30 Healthy Female Volunteers Over 3 Treatment Cycles

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) 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
Active Comparator: Arm 2	Drug: SH D01155E per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Arm

Intervention/Treatment

Experimental: Arm 1

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

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

Active Comparator: Arm 2

Drug: SH D01155E

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

Outcome Measures

Primary Outcome Measures

Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover [Baseline, Cycle 3 of each treatment period]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy female volunteers

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dinox B.V.	Groningen		Netherlands	9713GZ

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00318799

Other Study ID Numbers:

91477
2005-004688-45
310122

First Posted:

Apr 27, 2006

Last Update Posted:

Nov 25, 2013

Last Verified:

Nov 1, 2013

Keywords provided by Bayer

prevention of unintended pregnancies

Study Results

No Results Posted as of Nov 25, 2013