A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception

Bayer842 enrolled

Overview

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women

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

842

Conditions

Contraception

Interventions

YasminDRUG

30 µg ethinylestradiol, 3mg drospirenone

MarvelonDRUG

30 µg ethinylestradiol, 150 µg desogestrel

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Chinese female requesting contraceptives Exclusion Criteria: * Vascular, metabolic, hepatic, renal, oncologic and other diseases

Locations (1)

Unnamed facility

Ask Contact, China

Outcomes

Primary Outcomes

The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.

Time frame: 13 treatment cycles (1 cycle= 28 days)

Secondary Outcomes

Weight changes

Time frame: 13 treatment cycles

Contraceptive reliability

Time frame: 13 treatment cycles

Effects on skin condition

Time frame: 13 treatment cycles

Changes in MDQ subscale scores

Time frame: 13 treatment cycles

Adverse Events

Time frame: the whole study period

Data from ClinicalTrials.gov

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