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
  Purpose

Birth Control Patch Study


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cycle control parameters and bleeding pattern indices [ Time Frame: Treatment cycles 2-7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 346
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920985

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00920985     History of Changes
Other Study ID Numbers: 91556
Study First Received: June 15, 2009
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Pregnancy prevention
Female contraception
Patch

Additional relevant MeSH terms:
Contraceptive Agents
Gestodene
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014