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US Cycle Control and Blood Pressure Study

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ClinicalTrials.gov Identifier: NCT00920985
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
Birth Control Patch Study

Condition or disease Intervention/treatment Phase
Contraception Drug: Gestodene/EE (FC Patch Low, BAY86-5016) Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women
Study Start Date : June 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Arm 1 Drug: Gestodene/EE (FC Patch Low, BAY86-5016)
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2

Active Comparator: Arm 2 Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1




Primary Outcome Measures :
  1. Cycle control parameters and bleeding pattern indices [ Time Frame: Treatment cycles 2-7 ]

Secondary Outcome Measures :
  1. Number of pregnancies while on treatment up to 14 days after removal of the last patch [ Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days ]
  2. Evaluation of blood pressure changes during the dosing-free interval [ Time Frame: 7 treatment cycles each consisting of 28 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subject requesting contraception
  • Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
  • Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication

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): NCT00920985


  Show 28 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00920985     History of Changes
Other Study ID Numbers: 91556
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: January 2014

Keywords provided by Bayer:
Pregnancy prevention
Female contraception
Patch

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