EU/LA Pearl Index Study - Transdermal Contraceptive Patch | NCT00914693

ID	Type	Description	Link
2008-004214-27	EudraCT Number
310801	Other Identifier	Company internal

Official Title

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 Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethinylestradiol/Gestodene (BAY86-5016)	Drug	7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen	Arm 1

Outcomes Module

Measure	Description	Time Frame
Occurrence of pregnancy		13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcomes

Measure	Description	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

Other Outcomes

Measure	Description	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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Lanús Oeste	Buenos Aires	1824	Argentina

References Module

Label	URL
Click here and search for Bayer Product information provided by EMA	View source

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Ancestor Terms

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D042782	Estrogenic Steroids, Alkylated
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists