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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00920985

Enrollment

346

Registered

2009-06-16

Start date

2009-06-30

Completion date

2010-09-30

Last updated

2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Pregnancy prevention, Female contraception, Patch

Brief summary

Birth Control Patch Study

Interventions

DRUGGestodene/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

DRUGOral 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cycle control parameters and bleeding pattern indices	Treatment cycles 2-7

Secondary

Measure	Time frame
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
Evaluation of blood pressure changes during the dosing-free interval	7 treatment cycles each consisting of 28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026