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US Cycle Control and Blood Pressure Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00920985
First received: June 15, 2009
Last updated: January 27, 2014
Last verified: January 2014

June 15, 2009
January 27, 2014
June 2009
August 2010   (final data collection date for primary outcome measure)
Cycle control parameters and bleeding pattern indices [ Time Frame: Treatment cycles 2-7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920985 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of blood pressure changes during the dosing-free interval [ Time Frame: 7 treatment cycles each consisting of 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
US Cycle Control and Blood Pressure Study
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

Birth Control Patch Study

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Contraception
  • 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
  • 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
  • Experimental: Arm 1
    Intervention: Drug: Gestodene/EE (FC Patch Low, BAY86-5016)
  • Active Comparator: Arm 2
    Intervention: Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
346
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00920985
91556
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP