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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318799
First Posted: April 27, 2006
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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 Intervention Phase
Pregnancy, Unplanned Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) Drug: SH D01155E Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover [ Time Frame: 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). [ Time Frame: Baseline, Cycle 3 of each treatment period ]
  • Adverse events [ Time Frame: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period ]

Enrollment: 29
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318799


Locations
Netherlands
Dinox B.V.
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00318799     History of Changes
Other Study ID Numbers: 91477
2005-004688-45 ( EudraCT Number )
310122 ( Other Identifier: Company internal )
First Submitted: April 26, 2006
First Posted: April 27, 2006
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Bayer:
prevention of unintended pregnancies

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Hemostatics
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Coagulants
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists