US Cycle Control and Blood Pressure Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Gestodene/EE (FC Patch Low, BAY86-5016); Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920985

91556

Details and patient eligibility

About

Birth Control Patch Study

Enrollment: 346 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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346 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Gestodene/EE (FC Patch Low, BAY86-5016)

Arm 2

Active Comparator group

Treatment:

Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A