US Cycle Control and Blood Pressure Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920985
• Other study ID #: 91556
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2009
• Last updated: September 23, 2015
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Birth Control Patch Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycle control parameters and bleeding pattern indices		Treatment cycles 2-7	No
Secondary	Number of pregnancies while on treatment up to 14 days after removal of the last patch		7 treatment cycles each consisting of 28 days and follow-up period of 14 days	No
Secondary	Evaluation of blood pressure changes during the dosing-free interval		7 treatment cycles each consisting of 28 days	No

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