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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:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00318799
First received: April 26, 2006
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318799

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00318799     History of Changes
Other Study ID Numbers: 91477, 2005-004688-45, 310122
Study First Received: April 26, 2006
Last Updated: November 6, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bayer:
prevention of unintended pregnancies

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

ClinicalTrials.gov processed this record on May 22, 2013