Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00910637

Enrollment

1502

Registered

2009-06-01

Start date

2009-05-01

Completion date

2010-12-13

Last updated

2021-04-08

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

This study is examining a birth control patch for 13 cycles (1 year).

Interventions

DRUGGestodene/EE Patch (BAY86-5016)

55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Requiring contraception * Normal cervical smear * Maximum age for smokers is 35 * 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
Occurrence of pregnancy (yes/no) while on treatment	13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary

Measure	Time frame
Vital signs	13 treatment cycles each consisting of 28 days
Physical and gynecological examinations	13 treatment cycles each consisting of 28 days
Laboratory assessments	13 treatment cycles each consisting of 28 days
Adverse events (AE monitoring)	13 treatment cycles each consisting of 28 days

Countries

United States

Outcome results

None listed

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