FC Patch Comparator Study

Bayer422 enrolled

Overview

The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

422

Conditions

Contraception

Interventions

BAY86-5016, SH P00331FDRUG

Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)

SH P00331NDRUG

Drug amount per patch: 0.6 mg EE2 + 6 mg NGM

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female volunteer aged 18-35, smokers 18-30 Exclusion Criteria: * Contraindications for using hormonal contraceptives

Locations (28)

Unnamed facility

Wörgl, Tyrol, Austria

Unnamed facility

Bregenz, Austria

Outcomes

Primary Outcomes

Bleeding pattern and cycle control

Time frame: 13 cycles

Number of pregnancies

Time frame: 13 cycles

Secondary Outcomes

Adverse events collection

Time frame: 13 cycles

Endometrial biopsy

Time frame: 13 cycles

Physical and gynecological exam

Time frame: 13 cycles

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.