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

Pregnancy, Unplanned Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318799
• Other study ID #: 91477
• Secondary ID: 2005-004688-4531
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2006
• Last updated: November 20, 2013
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy female volunteers

Exclusion Criteria:

• Pregnancy or lactation

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy, Unplanned

Intervention

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
• SH D01155E
per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Locations

Country	Name	City	State
Netherlands	Dinox B.V.	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover		Baseline, Cycle 3 of each treatment period	No
Secondary	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	No
Secondary	Adverse events		2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period	Yes

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