Many Locations, South Korea
NCT Number: NCT00998257
Regulatory Post Marketing Surveillance Study on YAZ
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy female subjects
- requesting contraception
- suggesting PMDD by Physician who are also requesting contraception
- with acne who are also requesting contraception
- Age: 18 - 50 years
- Women who is prescribed YAZ first, during study period
Exclusion criteria
- Women who are contraindicated based on the label of YAZ
- Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
- Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
- History of migraine with focal neurological symptoms
- Diabetes mellitus with vascular involvement
- The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
- Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal
- Severe renal insufficiency or acute renal failure
- Presence or history of liver tumours (benign or malignant)
- Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
- Undiagnosed vaginal bleeding
- Known or suspected pregnancy
- Hypersensitivity to the active substances or to any of the excipients
Treatment and study plan
EE20/DRSP (YAZ, BAY86-5300)
DrugPatients under daily life treatment with YAZ according to local drug information.
Primary outcomes
-
Adverse event collection
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
-
Contraception efficacy
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
-
Drug compliance
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
-
Release of Premenstrual Dysphoric Disorder (PMDD) or acne
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Secondary outcomes
-
Number of patients who used YAZ just for contraception
Time frame: At initial visit (Day 0)
-
Number of patients who used YAZ for PMDD + contraception
Time frame: At initial visit (Day 0)
-
Number of patients who used YAZ for Acne + contraception
Time frame: At initial visit (Day 0)
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Oct 20, 2009
- Registry last updated
- Jan 21, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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