Regulatory Post Marketing Surveillance Study on YAZ

Contraception Clinical Trial

Official title:

Regulatory Post Marketing Surveillance Study on YAZ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998257
• Other study ID #: 14785
• Secondary ID: YA0910KRYAZ rPMS
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: January 19, 2015
• Start date: July 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acne
• Contraception
• Premenstrual Syndrome

Intervention

Drug:
• EE20/DRSP (YAZ, BAY86-5300)
Patients under daily life treatment with YAZ according to local drug information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event collection		After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)	Yes
Primary	Contraception efficacy		After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)	No
Primary	Drug compliance		After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)	No
Primary	Release of Premenstrual Dysphoric Disorder (PMDD) or acne		After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)	No
Secondary	Number of patients who used YAZ just for contraception		At initial visit (Day 0)	No
Secondary	Number of patients who used YAZ for PMDD + contraception		At initial visit (Day 0)	No
Secondary	Number of patients who used YAZ for Acne + contraception		At initial visit (Day 0)	No

External Links

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