Trial Condition(s):
Contraception
A clinical study on Yasmin® vs. Marvelon® in Chinese Women requiring contraception
Bayer Identifier:
91330
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
Inclusion Criteria
- Healthy Chinese female requesting contraceptives
Exclusion Criteria
- Vascular, metabolic, hepatic, renal, oncologic and other diseases
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site ask Contact, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An open-label, randomised, parallel-group comparison to investigate the efficacy of Yasmin® (30 µg ethinylestradiol, 3mg drospirenone) and Marvelon® (30 µg ethinylestradiol, 150 µg desogestrel) on cycle control in healthy Chinese women over 13 cycles
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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.Timeframe: 13 treatment cycles (1 cycle= 28 days)
Secondary Outcome
- Weight changesTimeframe: 13 treatment cycles
- Contraceptive reliabilityTimeframe: 13 treatment cycles
- Effects on skin conditionTimeframe: 13 treatment cycles
- Changes in MDQ subscale scoresTimeframe: 13 treatment cycles
- Adverse EventsTimeframe: the whole study period
Additional Information
Copyright © Bayer
Powered by
