FC Patch Low: Metabolism Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00933179

Purpose

The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.

Condition	Intervention	Phase
Contraception	Drug: Gestodene/EE Patch (BAY86-5016) Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Ethinyl estradiol Gestodene Levonorgestrel

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Prothrombin fragment 1+2, D-dimer [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Procoagulatory parameters [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]
Anticoagulatory parameters [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]
Thrombin and Fibrin turnover parameters [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Gestodene/EE Patch (BAY86-5016) 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles
Arm 2: Active Comparator	Drug: EE/Levonorgestrel (Microgynon, BAY86-4977) 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy woman requesting contraception
Normal cervical smear not requiring further follow-up
History of regular cyclic menstrual periods
Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

Exclusion Criteria:

Pregnancy or lactation
Obesity (Body Mass Index [BMI] > 30.0 kg/m2)
Any diseases or conditions that can compromise the function of the body systems
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Any disease or condition that may worsen under hormonal treatment
Undiagnosed abnormal genital bleeding
Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933179

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Germany
	Recruiting
Berlin, Germany, 10115

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

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91557, EudraCT: 2008-007024-26
Study First Received:	July 3, 2009
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00933179 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Prevention of pregnancy

Study placed in the following topic categories:

Estrogens
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Estradiol 17 beta-cypionate

Hormones
Hemostatics
Estradiol
Gestodene
Progestins
Levonorgestrel
Estradiol 3-benzoate
Ethinyl Estradiol-Norgestrel Combination
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Reproductive Control Agents

Hormones
Pharmacologic Actions
Gestodene
Progestins
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 10, 2009