EU/LA Pearl Index Study - Transdermal Contraceptive Patch

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 (Material no. 80876395) 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

NCT00914693

Enrollment

1694

Registered

2009-06-05

Start date

2009-04-30

Completion date

2011-09-30

Last updated

2014-12-05

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

Conditions

Contraception

Keywords

Fertility control, Contraception

Brief summary

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

Interventions

DRUGEthinylestradiol/Gestodene (BAY86-5016)

7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Inclusion criteria

* Requiring contraception * Normal cervical smear * Smokers not older than 30 years * History of regular cyclic menstrual periods

Exclusion criteria

* Pregnancy or lactation * Obesity (BMI\> 30 kg/m2 * 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	13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary

Measure	Time frame
Cervical smear	13 treatment cycles each consisting of 28 days
Adverse events	13 treatment cycles each consisting of 28 days
Bleeding pattern and cycle control	13 treatment cycles each consisting of 28 days

Other

Measure	Time frame
Treatment compliance	13 treatment cycles each consisting of 28 days
Subjective assessment of satisfaction with the treatment	13 treatment cycles each consisting of 28 days

Countries

Argentina, Australia, Chile, France, Germany, Italy, Mexico, Spain

Outcome results

None listed

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